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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
Please  note that Quality College workshops require separate registration.

Please review the Safety Rules and Guidelines.

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Saturday, April 7
 

9:00am PDT

3:00pm PDT

Registration Desk Open
Saturday April 7, 2018 3:00pm - 5:00pm PDT
Platinum Registration
 
Sunday, April 8
 

7:00am PDT

Quality College Continental Breakfast
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Hotel Breakfast Breads
Served with Preserves, Butter
Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Fresh Cage Free Scrambled Eggs
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Sunday April 8, 2018 7:00am - 8:00am PDT
Marquis Ballroom South

7:00am PDT

Registration Desk Open
Sunday April 8, 2018 7:00am - 5:00pm PDT
Platinum Registration

8:00am PDT

Workshop 1 - GLP 101: Basic Training (2 days)
RQAP re-registration units: 4 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units

Description
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study. The course also provides a review of GLP history, examination of the FDA Preambles, offers topical comparisons between FDA and EPA requirements and OECD Principles, and is intended to equip the participant with a working knowledge of GLP impacts on study conduct. Opportunities for group interaction and breakout periods help widen the educational exchange while enhancing the learning process.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the regulatory requirements for nonclinical laboratory facilities, equipment, personnel, methods, practices, records and controls to assure Management of compliance or report the lack thereof
  • Identify compliance gaps in the overall quality system of a facility and suggest improvements based upon regulatory requirements
  • Effectively communicate the requirements of FDA GLPs and identify topical differences between FDA and EPA requirements and OECD Principles of GLP
  • Interpret and apply GLP requirements using a variety of resources
  • Use the knowledge obtained by completing the training exercises to increase effectiveness in current role

Target Audience
This course is a comprehensive introduction to FDA Good Laboratory Practice regulations or refresher training for all personnel involved in a nonclinical laboratory study.

Agenda
  • Basic GLP Training Overview
  • Landmark Cases in the Development of GLP
  • Organization of the GLP Regulations
  • Scope and Definitions
  • Contracting Under GLPs and Inspections of Testing Facilities
  • Organization and Personnel
  • Facilities
  • Equipment
  • Testing Facilities Operation
  • Test and Control Articles
  • The Protocol
  • Conduct of Nonclinical Laboratory Studies
  • Reporting of a Nonclinical Laboratory Study
  • Storage, Retrieval, and Retention
  • Electronic Record Keeping in Nonclinical Laboratory Studies
  • Shall vs. Should
  • FDA/EPA Regulations vs. OECD Principles of GLP


Speakers
avatar for Greg Furrow

Greg Furrow

Vice President, Quality and Compliance, Southern Research
Greg Furrow is vice president of Quality and Compliance at Southern Research Institute where he is responsible for Quality Assurance, EH&S, Biosafety, Export Control, Government Security, Information Technology, Human Resources and quality improvement processes. He has been at Southern... Read More →
avatar for Beth Moulaison

Beth Moulaison

Vertex
Beth Moulaison joined Vertex in 2016 and is currently the Director of R&D Quality Assurance overseeing nonclinical and clinical activities conducted in compliance with industry standards and regulations. Prior to joining Vertex, Beth worked for Shire (2012-2016) while employed there... Read More →
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →
avatar for Thomas Purdue

Thomas Purdue

QA Compliance Analyst V, Boehringer Ingelheim Pharmaceuticals, Inc
Mr. Purdue is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) and has over 25 years of experience in performing GLP audits of facilities and studies to comply with U.S. FDA, EPA, European, and Japanese GLP regulations. He has 10 years’ experience in GMP Quality Assurance... Read More →
avatar for Sara Rybak

Sara Rybak

Manager, Charles River
Sara Rybak BS, RQAP-GLP is the Manager of Regulatory Compliance at the Charles River site based in Skokie IL (formerly WIL Research, Midwest BioResearch). In this position she manages a team of auditors who regularly perform audits of genetic toxicology and large molecule bioanalytical... Read More →
avatar for Gina Tucker

Gina Tucker

Senior Validation Specialist, Southern Research Institute
Ms. Tucker is a Senior Validation Specialist with the Southern Research Quality Department. Ms. Tucker received her Bachelor of Science from Mount St. Mary’s College and Masters of Business Administration Degrees from Mount St. Mary’s University. She joined Southern Research in... Read More →
avatar for Lori Wright

Lori Wright

Manager, Quality and Compliance, Southern Research
Lori Wright, RQAP-GLP is Manager, Quality and Compliance at Southern Research in Birmingham, AL. Her responsibilities include vendor audits, training, business process improvement, facility audits, and managing the document control process and archives. She is also serving as the... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 1&2

8:00am PDT

Workshop 2 - GCP 101: Understanding the Basics (2 days)
RQAP re-registration units: 4 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This is a basic course providing an overview of the fundamentals of Good Clinical Practice. Exercises will be conducted including review of electronic documents. Topics include: Principles of GCP, Key Regulations and Guidelines, Audit Standards, and applying them to several types of GCP audits. A mock audit exercise will be conducted to give some hands-on experience.

Objectives
At the end of the course, the participants shall be able to: 
  • Define Good Clinical Practices.
  • Identify the contents of GCPs.
  • Find key regulations within 21 CFR and ICH GCP E6(R2).
  • Describe 3-4 Activities to be performed during an audit.

Target Audience
This course is for clinical auditors with less than 1 year experience, or GMP/GLP auditors with no GCP experience.

Agenda
  • Principles of GCP
  • Key Regulations and Guidelines
  • Electronic Records and eSignatures
  • Protection of Human Subjects
  • Institutional Review Boards / Ethics Committees
  • Financial Disclosure
  • Clinical Trial Essential Documents
  • Drug Accountability
  • Safety Reporting
  • Investigator Site Audits
  • Service Provider Audits
  • Internal Audits
  • Regulatory Inspections


Speakers
avatar for Tony Brewer

Tony Brewer

Associate Director, Quality Assurance, Syneos Health
avatar for Jacqueline Bushong

Jacqueline Bushong

Director, CQA, Atara Biotherapeutics
Jacqueline (Jackie) Bushong RQAP-GCP, is the Director / Head of Clinical Quality Assurance at Atara Biopharmaceuticals in Westlake Village, CA. She has 20+ years of experience in pharmaceutical/biotech industry in the CQA profession. Previous employers include Kythera, Amgen, Chiron... Read More →
avatar for Jamie Colgin

Jamie Colgin

President, Colgin Consulting, Inc.
Jamie Colgin, President of Colgin Consulting, Inc., helps Pharmaceutical, Biopharmaceutical, and Contract Research Organizations assure the integrity of their clinical data through Risk Assessments, Data Integrity Audits, Mock Inspections, Remediation Assistance, and Training. With... Read More →
avatar for Cheryl McCarthy

Cheryl McCarthy

Associate Director, Biogen
Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director... Read More →
avatar for Jenny O'Brien

Jenny O'Brien

Clinical QA Consultant, OBrien CQA, LLC
Jenny O’Brien is a Quality Assurance Professional with over 20 years of experience in the drug development/CRO industry. Dr. O’Brien is committed to providing GCP services with integrity and excellence. Her GCP QA experience includes site audits, vendor audits, process mapping... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 3

8:00am PDT

Workshop 3 - CAPA 101: Problem Definition - Beyond Human Error (1 day)
RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
Fundamental to an effective CAPA program is the practical application of Root Cause Analysis (RCA) and developing an understanding of the root cause(s), contributing cause(s), and possible cause(s) of the issue/problem. Defining the problem - setting boundaries - is integral to enabling an effective RCA. This course will provide tools, insight and best practice to support continuous process improvement and enable sustained results by emphasizing approaches to defining the problem and analyzing the causal factors. A common deficiency in many Industry CAPA programs is a myopic RCA identifying human error and solely prescribing training as the preventive mitigation. By going beyond human error and training, the effective CAPA program becomes a systematic assessment, focusing less on the individual and more on the process(es) in place (What about the process that allowed the issue to occur?) and the process quality control (What about the process that allowed the issue not to be detected?).

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the difference between reactive and proactive
  • Understand the advantage of a systematic methodology
  • Know what is CAPA?
  • Define a problem (case studies to be provided for hands-on)
  • Understanding high level process mapping
  • Apply root cause analysis, including process tools (fishbone/is-is not/5 Whys)
  • Develop corrective action that addresses the Root Cause

Target Audience
Basic

Speakers
avatar for Eric Humes

Eric Humes

Executive Director, QA, Medpace
Eric Humes is Executive Director, Quality Assurance at Medpace. Medpace is a full-service global contract research organization providing drug, biological and medical device development expertise from test-tube to marketing approval. Mr. Humes has a broad range of industry experience... Read More →
avatar for Donna McElcar

Donna McElcar

Clear CQA
  
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 4

8:00am PDT

Workshop 4 - CSV 101: Basic Concepts in Computer Validation (2 days)
RQAP re-registration units: 4 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Objectives
At the end of the course, the participants shall be able to: 
  • Provide a thorough understanding of computer system validation by providing a framework on how to execute the System Life Cycle.
  • Address how 21 CFR Part 11 (electronic record/electronic signature requirements) fits into the validation process.
  • Be familiar with expected content for computer validation deliverables through workshop exercises and examination of example documents, as well as how to develop the validation rationale for a variety of circumstances.

Target Audience
This course is designed for Validation, Quality, IT, and Business personnel responsible for implementing and using regulated computer systems in the pharmaceutical, biotech and medical device industries. The course is of special value to personnel seeking experience with computer validation and issues associated with regulated computer systems. The course is especially designed for attendees seeking a thorough introductory level of understanding, yet is also designed to be valuable to those with prior experience seeking to remain current with industry trends and approaches.

Agenda
  • Understanding the Regulations and Guidelines.
  • Identifying the Components of the System Life Cycle.
  • In-depth look at the Validation Deliverable.
  • Planning, Conducting and Documenting the Computer Validation Audit.


Speakers
avatar for Helene Andersson

Helene Andersson

Quality Assurance Manager, Toxikon Corporation
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Frank Moschetto

Frank Moschetto

Propietor/Principal Consultant, Frank M Consulting LLC
Mr. Moschetto has worked in the pharmaceutical industry for over 30 years, in research and development primarily in a GLP/GCP environment, and has performed inspections of Computer System Validations, and Data Centers & Host (Cloud) facilities in preparation for several SaaS (Software... Read More →
avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 7

8:00am PDT

Workshop 5 - GMP 101: Basic Training: History and Intro of US FDA GMPs (1 day)
RQAP re-registration units: 2 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course provides a history of the GMP regulations, what is the purpose, why were they created, how did they develop over time and an overview of the sections of the regulations.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose of the GMP regulations.
  • How the regulations developed over time.
  • Provide an overview of the regulations.

Target Audience
Quality Assurance professionals and management looking for an overview of the GMP regulations.

Agenda
  • History and Introduction of the US FDA GMPs
  • Overview of 21CFR Parts 210 and 211
  • Out of Specifications
  • SOPs
  • QA versus QC
  • Review of Warning Letters


Speakers
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →
avatar for Christine Garvey

Christine Garvey

Senior Manager, Regualtory Compliance, Charles River Laboratories, Inc
Christine Garvey is the Senior Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GMP testing conducted at the Wilmington MA and Woburn MA sites. She started her career performing radiologic testing, transferring into... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 8

8:00am PDT

Workshop 6 - GCP 301: Audits in Biostatistics (1 day)
RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
GCP Audits in biostatistics are a relatively rare occurrence, especially when compared to the vast number of investigator site audits in a clinical trial. Reasons for this include that biostatistics processes are done only once for a clinical trial regardless of the number of trial sites included and subjects enrolled. Also because of the strong focus on investigator site audits, many GCP auditors have little opportunity and therefore lack the knowledge to perform audits in biostatistics. The course offers a unique training opportunity for GCP auditors to be better equipped to assess data integrity and enhance inspection readiness in biostatistics.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand core procedures in biostatistics related to the conduct of clinical trials
  • Know the GCP regulatory requirements and expected documentation for biostatistics
  • Perform audits and identify deficiencies and weaknesses in biostatistics procedures followed in GCP trials

Target Audience
GCP auditors with an interest in broadening their audit portfolio and wish to assess processes in biostatistics. Experience in the conduct of GCP audits is expected for this course. Biostatisticians who are interested to learn what GCP auditors are looking for in such audits and would like to be better prepared for audits and inspections.

Agenda
  • 08:00 - 09:00 Introduction, GCP Requirements pertinent to Biostatistics
  • 09:00 - 10:00 Overview on GCP Audits (preparation, conduct, follow-up)
  • 10:15 - 12:00 Auditing Biostatistics Processes (Part I): Protocol and Amendments, Sample Size Estimation, Randomization, Data Monitoring Committee
  • 13:00 - 15:00 Auditing Biostatistics Processes (Part II): Statistical Analysis Plan, Statistical Analysis Programming, Interim Analysis, (Blind) Data Review Meeting
  • 15:15 - 16:30 Auditing Biostatistics Processes (Part III): Unblinding & Final Analysis, Statistical Report & Final Report, Validation of Computerized Systems
  • 16:30 - 17:00 Wrap-Up, Questions & Answers
The course includes four exercises:
1. Protocol Sections on Statistics
2. SAP and Tracking Sheet
3. Table and Figure
4. CSR and Protocol Deviations

Speakers
RH

Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Allan Rosen

Allan Rosen

Chief Scientific Officer, Array Biostatistics
Allan Rosen, MS is Chief Scientific Officer at Array Biostatistics, a company which provides statistical and statistical programming services to the pharmaceutical, medical device, and biotechnology industry. He has over 35 years of experience in clinical trial research including... Read More →


Sunday April 8, 2018 8:00am - 5:00pm PDT
Platinum 9

10:00am PDT

Quality College Beverage Break
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

Sunday April 8, 2018 10:00am - 10:15am PDT
Platinum Foyer

12:00pm PDT

Quality College Networking Lunch
The Food Court Buffet Caesar Salad
Mixed Green Salad Grilled Vegetable Wrap
BBQ Chicken Sandwich on Ciabatta with Chipotle Aioli
Beef Tenderloin with Boursin Cheese and Onion Straws on Asiago Sourdough House-Made Yukon Gold Chips
Lemon Meringue Tart
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk)
 Iced Tea

Sunday April 8, 2018 12:00pm - 1:00pm PDT
Marquis Ballroom South

3:00pm PDT

Quality College Beverage and Snack Break
Assorted Freshly Baked Brownies Assorted Soft Drinks (Pepsi Products) Bottled Water
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Sunday April 8, 2018 3:00pm - 3:15pm PDT
Platinum Foyer
 
Monday, April 9
 

7:00am PDT

Quality College Continental Breakfast
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Hotel Assorted Muffins
Served with Preserves, Butter
Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Hard Boiled Eggs
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Monday April 9, 2018 7:00am - 8:00am PDT
Marquis Ballroom South

7:00am PDT

Registration Desk Open
Monday April 9, 2018 7:00am - 6:00pm PDT
Platinum Registration

8:00am PDT

Workshop 10 - GLP 301: Metrics and You: Perfect Together (1/2 day)
RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
It's all about the data. In a study, that data is the raw data. For Testing Facility Management in a GLP facility, that data is metrics. During this course, we will explore perspectives of QA and Testing Facility Management on value-added metrics and how to use them to make sound decisions for improving operations.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify 3 ways in which QA and Operations metrics can be utilized in a GLP laboratory.
  • List 3 types of metrics that could be implemented in a GLP laboratory.
  • Analyze the data from the metrics to make recommendations.

Target Audience
GLP QA management and Testing Facility Management responsibilities.

Agenda
  • Opening Overview of Metrics
  • QA Perspective and Data on Metrics
  • TFM and Operations Perspective on Metrics
  • Operational Data
  • Group exercise
  • Summary


Speakers
avatar for Nancy Catricks

Nancy Catricks

Senior Director, North American GLP QA, Charles River Laboratories
Nancy Catricks, MS, is Senior Director, North American GLP QA at Charles River Laboratories. She is responsible for the management of the Quality Assurance Unit at the Charles River Safety sites across North America. Ms. Catricks received her Bachelor of Science degree in Small Animal... Read More →
avatar for Pamela Shaver-Walker

Pamela Shaver-Walker

Executive Director, Process Optimization, Charles River Labs
Pamela Shaver Walker, MSc is the Executive Director of Process Optimization for Charles River Laboratories Safety Assessment. In this role, Pam uses metrics every day and is particularly enthusiastic about them. Before working in Optimization, Pam worked at Charles River as a Study... Read More →
MV

Matthew Vaneman

Vice President of Operations Excellence, Charles River
As Vice President of Operational Excellence, Mr. Vaneman is responsible for all facets of Global Harmonization for Charles River. Mr. Vaneman has oversight for Global Operation and Scheduling for the Safety Assessment segment of Charles River. Mr. Vaneman is responsible for creating... Read More →


Monday April 9, 2018 8:00am - 12:00pm PDT
Platinum 10

8:00am PDT

Workshop 8 - GLP 103: Basic GLP Archiving (1/2 day)
RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will provide participants with an overview of GLP archiving and lay the foundation for requirements, critical thinking and agency expectations.

Objectives
At the end of the course, the participants shall be able to: 
  • Gain an understanding of GLP archiving
  • Identify archiving risk areas within an archive
  • Provide value to his/her site by educating internal and external clients on archiving requirements

Target Audience
The target audience for these sessions will be for new GLP archivists. Topics will range from the basics of archiving to electronic archiving and everything in between. While new members will get the most out of the class, seasoned archivists will find the courses beneficial as a refresher and to share ideas and experiences.

Agenda
  • 8:00-8:15 Welcome, Logistics and Introductions
  • 8:15-9:30 The Who, What, When, Where, Why, & How of GLP Archiving
  • 9:30-10:00 Electronic Archiving
  • 10:00-10:15 Beverage break
  • 10:15-10:30 Electronic Archiving
  • 10:30-11:45 Auditing the Archive
  • 11:45-12:00 Q&A and Wrap up


Speakers
avatar for Arif Demirel

Arif Demirel

Senior Manger, Archives, Charles River Labs
Arif Demirel is the Senior Manager of Archives at Charles River Laboratories and oversees the global archiving operations for Charles River. He has served in various roles, including reporting and GLP auditing. He is the current SASS chair and IACUC chair at Charles River - Horsham... Read More →
avatar for Colleen Hanson

Colleen Hanson

Supervisor, Document Control/Training and Archives, SNBL USA
Colleen Hanson is Supervisor of the Document Control/Training and Archives department within SNBL USA. Colleen has spent the last 20 years working at CRO's with the last 17 as the Archivist for GLP facilities.


Monday April 9, 2018 8:00am - 12:00pm PDT
Platinum 8

8:00am PDT

8:00am PDT

8:00am PDT

8:00am PDT

Workshop 7 - CAPA 201: Creation and Effectiveness - (Across GxPs) (1 day)
RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
An effective CAPA process begins with Root Cause Analysis and ends with CAPA Effectiveness. The process requires strategic direction, risk assessment, effective communication, accountability and responsibility agreed and clearly defined. This course will take a deep dive into the CAPA Process; the purpose, effective CAPA creation and how to use the information for fundamental organization change.

Objectives At the end of the course, the participants shall be able to: 
  • Understand the value of an organization CAPA Process
  • Move from Root Cause identified to corrective and preventative action by:
  • Developing a CAPA that addresses the Root Cause (case studies to be provided for hands-on)
  • Ensure CAPA is valid and validated
  • Effectiveness checking of CAPA via internal audit review
  • Systematically implement global CAPA process

Target Audience
Intermediate to advanced. Must have completed the CAPA Problem Definition - Beyond Human Error class or have a solid understanding of Root Cause Analysis.

Agenda
  • 8:00 am - 10:00 am
  • Review of Problem Definition and Root Cause Analysis
  • Group Refresher Root Cause Analysis
  • 10:00 am - 10:15 am
  • Break
  • 10:15 am - 12:00 pm
  • The Purpose of a CAPA
  • How to Facilitate CAPA Effectiveness
  • Group Practice (CAPA Steps 5-6)
  • 12:00 pm - 1:00 pm
  • Lunch Break
  • 1:00 pm -3:00 pm
  • Group Practice and Report
  • Fundamental Change through Trend Analysis and Process Improvement
  • 3:00 pm - 3:15 pm
  • Break
  • 3:15 pm - 5:00 pm
  • CAPA Systems
  • Group Scenario - CAPA Systems and Communication
  • Q&A


Speakers
BF

Bob Figarotta

Associate Director - Clinical Quality, Allergan
Bob Figarotta is an Associate Director – Clinical Compliance, Global Regulatory and Development Quality at Allergan, operating out of the Irvine, California office. His current responsibilities include leading the GCP System Audit program. He has been auditing in the evolving GCP... Read More →
avatar for Eric Humes

Eric Humes

Executive Director, QA, Medpace
Eric Humes is Executive Director, Quality Assurance at Medpace. Medpace is a full-service global contract research organization providing drug, biological and medical device development expertise from test-tube to marketing approval. Mr. Humes has a broad range of industry experience... Read More →
avatar for Donna McElcar

Donna McElcar

Clear CQA
  
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →


Monday April 9, 2018 8:00am - 5:00pm PDT
Platinum 4

8:00am PDT

Workshop 9 - GCP 202: Hot Topics & Industry Trends (1 day)
RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This interactive workshop will provide experienced GCP QA professionals with additional skills and techniques to expand their knowledge and implementation of important new topics and trends in the QA field. This session has been designed to provide best practices and audience participation activities in employing effective interview techniques, preparing for upcoming Device GCP changes in the EU, understanding the MDSAP program and upcoming organizational and outreach efforts by US FDA. In addition to these topics, this session will also provide the regulatory perspective as it relates to the current status of GCPs as experienced in the global community.

Objectives
At the end of the course, the participants shall be able to: 
  • Apply more effective interview techniques during audits
  • Describe important upcoming changes to Device GCPs in the EU
  • Discuss pros and cons of the MDSAP program
  • Explain FDA re-organization and outreach efforts (FDA Rep to be invited)

Target Audience
GCP professionals with 2 or more years of experience.

Agenda
  • Overview of Quality Management in Clinical Trials E6(R2) focus
  • Understanding the MDSAP program
  • Preparing for EU Regulatory Device GCP changes
  • Employing Effective Interview Techniques When Auditing
  • FDA Re-organization and Outreach Activities Update


Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Glenda Guest

Glenda Guest

President, Assured of Quality Consulting & Training
Glenda Guest CCRA, RQAP-GCP, TIACR has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession... Read More →
avatar for Lee Truax-Bellows

Lee Truax-Bellows

President, CRO, NCRA
Lee Truax Bellows, RQAP-GCP, CCRALee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a GCP Quality Auditor, Trainer, and Project Manager. Lee has been involved in regulated research for the past 28 years... Read More →


Monday April 9, 2018 8:00am - 5:00pm PDT
Platinum 9

9:00am PDT

Speaker Ready Room
Stop by and upload or make changes to your presentation.

Monday April 9, 2018 9:00am - Thursday April 12, 2018 5:00pm PDT
Elite 3

10:00am PDT

Quality College Beverage Break
 Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

Monday April 9, 2018 10:00am - 10:15am PDT
Platinum Foyer

12:00pm PDT

Quality College Networking Lunch
Southern Comfort Buffet Biscuits and Corn Bread
Butter Lettuce, Romaine, Heirloom Tomato Salad, Served With a Buttermilk Ranch Dressing Roasted Root Vegetables
Yukon Mash Potatoes
Bourbon Barbecue Grilled Chicken
Ale Braised Beef Brisket
Vegetarian Options: Green Bean Sweet Corn Barley
Strawberry Shortcake
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk)
Iced Tea

Monday April 9, 2018 12:00pm - 1:00pm PDT
Marquis Ballroom South

1:00pm PDT

Workshop 11 - GLP 203: Intermediate GLP Archiving (1/2 day)
RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will provide participants with a detailed overview of archiving and the regulatory landscape.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify GLP risk areas in an archive
  • Develop a robust chain of custody process for the transfer of archived material
  • Provide value to his/her site by educating internal and external clients on archiving requirements

Target Audience
Archiving 201 is targeted for seasoned archivists with a more detailed look at the regulatory landscape and agency expectations.

Agenda
  • 1:00-1:10 Welcome, Logistics and Introductions
  • 1:10-1:15 Regulatory Landscape
  • 1:15-2:15 My archive is moving. What should I do and expect?
  • 2:15-3:00 Records Management - A corporate approach
  • 3:00-3:15 Beverage break
  • 3:15-4:30 Electronic Archiving
  • 4:30-5:00 Q&A and Wrap up


Speakers
avatar for Arif Demirel

Arif Demirel

Senior Manger, Archives, Charles River Labs
Arif Demirel is the Senior Manager of Archives at Charles River Laboratories and oversees the global archiving operations for Charles River. He has served in various roles, including reporting and GLP auditing. He is the current SASS chair and IACUC chair at Charles River - Horsham... Read More →
avatar for Kathryn Newland

Kathryn Newland

DSRD Global Compliance & Records Management Lead, Pfizer
Kathryn Newland is the Global Compliance & Records Management Lead with Regulatory Strategy and Compliance in Drug Safety Research & Development at Pfizer, Inc. Her responsibilities include leadership and management of the combined Compliance & Records Management organization, setting... Read More →
avatar for Thomas Purdue

Thomas Purdue

QA Compliance Analyst V, Boehringer Ingelheim Pharmaceuticals, Inc
Mr. Purdue is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) and has over 25 years of experience in performing GLP audits of facilities and studies to comply with U.S. FDA, EPA, European, and Japanese GLP regulations. He has 10 years’ experience in GMP Quality Assurance... Read More →


Monday April 9, 2018 1:00pm - 5:00pm PDT
Platinum 10

1:00pm PDT

Workshop 12 - General 102: SQA Leadership Development (1/2day)
RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
The SQA Board of Directors has created this course for SQA members. This course is designed to provide SQA members with tools and skills that will enable them to be better leaders in both SQA volunteer leadership positions as well as in other areas of their lives. It will provide a better understanding of SQA leadership responsibilities and an understanding of how SQA is governed. SQA members who are considering running for election or volunteering on Committees or within Specialty Sections will gain a better understanding of the requirements and responsibilities of the positions and the resources and assistance SQA offers to support those positions;. It will also provide an opportunity to meet and network with past, current and future SQA leaders and to develop and discuss leadership concepts through fun group exercises.

Objectives
At the end of the course, the participants shall be able to: 
  • Describe how to attract appropriate volunteers and how to get them actively involved.
  • Discuss methods of motivating and rewarding volunteers.
  • Describe how various leadership activities are linked to the SQA strategic plan.
  • Implement effective leadership transition (when leaving a leadership position) so that progress can continue.
  • Demonstrate practical and effective communication techniques.
  • Identify who to ask for help with SQA leadership activities.
  • Use the SQA website to effectively lead and manage committees, specialty sections and/or other ad hoc groups and subcommittees within SQA.
  • Use SQA Headquarters services to minimize workload and maximize results.

Target Audience

This course is directed at SQA members who wish to become further involved with SQA in a leadership capacity, are considering becoming a future SQA leader or wish to further develop or gain knowledge of leadership skills.

Agenda
  • Why
  • What
  • How (exercises)
  • If (panel)
  • Volunteers: what are they and why are they important
  • Finding appropriate volunteers
  • Why volunteer – WIIFM
  • Motivating and empowering volunteers
  • Leading long-distance committees
  • Goal planning
  • Determining and retaining members
  • How to inspire, delegate, motivate, assign tasks, follow-up on tasks
  • Fine art of delegation
  • Transition of volunteers/chair
  • Evaluating how you are doing
  • Thank you notes
  • EXERCISE: Communication
  • Aligning with the SQA Strategic Plan
  • Minutes and reports
  • Website use
  • SQA conference lines
  • Maintaining membership list (Volunteer Commitment Form)
  • EXERCISE: Game
  • Current Leader Panel/Q & A
  • (5 min personal story from panelists)


Speakers
avatar for Kimberly Frazier

Kimberly Frazier

Consultant, Kim Frazier Consulting, LLC
Kimberly Frazier is the Principal Consultant of Kim Frazier Consulting, LLC located in Mattawan, MI providing consulting services in GLP Quality Assurance and Animal Welfare Compliance. For the last twenty-five years, she has worked in various aspects of the regulatory environment... Read More →
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →
avatar for Lucy Wingett

Lucy Wingett

Head of GLP Strategy, Genentech, Inc.


Monday April 9, 2018 1:00pm - 5:00pm PDT
Platinum 8

3:00pm PDT

Quality College Beverage and Snack Break
Veggies & Hummus and Assorted Soft Drinks (Pepsi Products) Bottled Water
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Monday April 9, 2018 3:00pm - 3:15pm PDT
Platinum Foyer

3:30pm PDT

5:30pm PDT

Opening Reception
Come relax and network with your colleagues to kick off the Annual Meeting with a variety of food truck offerings (complimentary to full meeting registrants) and a cash bar (one complimentary drink ticket)!

Food Trucks: Baby’s Burgers, Tropic Truck, Richeeze, India Jones, & Meat The Greek

Monday April 9, 2018 5:30pm - 7:00pm PDT
Grand Plaza, Center and West
 
Tuesday, April 10
 

7:00am PDT

Registration Desk Open
Tuesday April 10, 2018 7:00am - 5:00pm PDT
Platinum Registration

7:15am PDT

Continental Breakfast with Exhibitors and Posters
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Hotel Breakfast Breads
Served with Preserves, Butter
Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Baja Breakfast Burrito, Scrambled Egg, Chorizo Sausage, Potato,
Aged Cheddar and Anaheim Fire Roasted Salsa (50% Vegetarian)
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Tuesday April 10, 2018 7:15am - 8:15am PDT
Marquis Ballroom

7:15am PDT

EPA-Subcommittee of the GLP Specialty Section (GLPSS) Breakfast
Please join other EPA-SC members for a breakfast meeting, with informal discussion of trending topics, possible webinar ideas for 2018, and emerging issues within the profession. All are welcome!  Hosted by Kim Watson and Kirsten Daigle.  

Tuesday April 10, 2018 7:15am - 8:15am PDT
La Jolla/Los Angeles, Lower Level

7:15am PDT

First-Time Attendee Breakfast
Join us for breakfast! Attending the SQA Annual Meeting for the first time can be overwhelming, which is why the Membership Retention & Development Committee (MRDC) has invited all first-time attendees to this special breakfast.

This event is a great opportunity for you to ask questions, interact with seasoned attendees, and learn the best ways to take advantage of all that is offered at the Annual Meeting.  We would love to see you there!

Tuesday April 10, 2018 7:15am - 8:15am PDT
Newport Beach/Rancho Las Palmas, Lower Level

7:15am PDT

Pacific Regional Chapter of SQA (PRCSQA)
The Pacific Regional Chapter of the Society of Quality Assurance (PRCSQA) will be having its Chapter meeting on Tuesday. If you are from the Pacific region, please come join us! Get a chance to network with your fellow Quality Assurance professionals in the Pacific region and get to know what is going on with your Regional Chapter. We hope to see you there!

Tuesday April 10, 2018 7:15am - 8:15am PDT
Orange County 3&4

8:15am PDT

Opening Plenary and Keynote Speaker
Welcome, Announcements and Awards, President's Speech, Keynote Presentation

Moderators
avatar for Lisa Sottolano

Lisa Sottolano

Charles River
Lisa Sottolano is the Director of Regulatory Compliance at Charles River, Massachusetts in Shrewsbury. As Director of Regulatory Compliance, Ms. Sottolano is responsible for QA operations at the site. Ms. Sottolano received a BA in Biological Sciences from Rutgers University and a... Read More →
avatar for Lori Wright

Lori Wright

Manager, Quality and Compliance, Southern Research
Lori Wright, RQAP-GLP is Manager, Quality and Compliance at Southern Research in Birmingham, AL. Her responsibilities include vendor audits, training, business process improvement, facility audits, and managing the document control process and archives. She is also serving as the... Read More →

Speakers
avatar for Tammy Barkalow

Tammy Barkalow

Assistant Director, Quality Assurance, The IR-4 Project
Tammy White Barkalow, RQAP-GLP is the Assistant Director of Quality Assurance at the Headquarters of the IR-4 Project, a USDA funded, cooperative research project. She is the 2018 President of the Society of Quality Assurance and has 28 years of experience in the QA/GLP arena. She... Read More →
avatar for Jeff Barnes

Jeff Barnes

Jeff takes the magic of Disney and connects it to your company's story showing you how to overcome obstacles, deal with difficulties, and inspires your team to go ALL IN on taking your business to the next level.Dr. Jeff Barnes is Dean of Student Success at California Baptist University... Read More →


Tuesday April 10, 2018 8:15am - 10:00am PDT
Platinum 5&6

10:00am PDT

Networking Break with Exhibitors and Posters
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Tuesday April 10, 2018 10:00am - 10:30am PDT
Marquis Ballroom

10:30am PDT

Morning Plenary
FDA BIMO Update (45 minutes) - Chrissy Cochran
Pre-approval Inspections, GMP Regulations and Data Integrity (45 minutes) Dr. Krishna Ghosh

Moderators
avatar for Beth Moulaison

Beth Moulaison

Vertex
Beth Moulaison joined Vertex in 2016 and is currently the Director of R&D Quality Assurance overseeing nonclinical and clinical activities conducted in compliance with industry standards and regulations. Prior to joining Vertex, Beth worked for Shire (2012-2016) while employed there... Read More →

Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

FDA
Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She has extensive experience... Read More →


Tuesday April 10, 2018 10:30am - 12:00pm PDT
Platinum 5&6

12:00pm PDT

Networking Lunch with Exhibitors and Posters
Taste of Italy Buffet Garlic Bread Sticks Caesar salad
Vine Ripe Tomatoes with Fresh Mozzarella
Basil and Extra Virgin Olive Oil and Grilled Vegetables Tuscan Roasted Chicken
Cheese Ravioli with Sage Cream
Tiramisu
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk)
Iced Tea

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

12:00pm PDT

12:00pm PDT

Articles of Incorporation and Bylaws Committee (AIBC)
A lunch table will be reserved for members of the Articles of Incorporation and Bylaws Committee.

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

12:00pm PDT

Canadian Chapter of SQA (CCSQA) Luncheon
Calling all Canadians!  Please join us, the Canadian Chapter of SQA (CCSQA) for lunch.  Meet and network with fellow Canadians in the industry.  Not currently a CCSQA member?  Not a problem, come and see what we are all about.  We look forward to seeing you and getting your feedback on ways to keep our members engaged.  See you then!

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Orange County 3

12:00pm PDT

Mid-Atlantic Region of SQA (MARSQA) Luncheon
MARSQA invites all members for a luncheon and networking session! The MARSQA board hopes to see you there!

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
La Jolla/Los Angeles, Lower Level

12:00pm PDT

National Capital Area Regional Chapter SQA (NCARSQA) Luncheon
Please come join the NCARSQA Board of Directors and other members for an informal lunch. Get the chance to network with other Quality Assurance professionals from the DC area and see what is going on with your local chapter. All are welcome and we hope to see you there!

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

12:00pm PDT

New England Regional Chapter SQA (NERCSQA) Luncheon
Please join us for NERCSQA Meet and Greet Lunch. We will introduce new officers attending and give you a brief program update for 2018. Bring a friend and join us!

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Orange County 4

12:00pm PDT

Rocky Mountain Regional Chapter SQA (RMRCSQA) Luncheon
Come meet the members of the Rocky Mountain Regional Chapter of the SQA. We will be discussing regional activities, membership and upcoming webinars

Tuesday April 10, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

1:30pm PDT

Session A - GLP Track
A-1  GLP Compliance Program Information

Abstract: TBA

Category: TBA

Level of Content: TBA

A-2  Globalization of QA/GLPs

Abstract: TBA

Category: 
TBA

Level of Content:
TBA

Moderators
avatar for Deborah Parker

Deborah Parker

QA Manager, ICON Bioanalytical Laboratories
Deborah Parker is a QA Manager at ICON PLC. She has over three decades of experience in the pharmaceutical industry, with training as a bioanalytical scientist. Having performed analysis using RIAs, Enzyme Inhibition testing, ELISAs, HPLC and LC-MS/MS, her background provided a perfect... Read More →

Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Bill Harrison

Bill Harrison

VP Toxicology & Global Head of Medical Device Testing, WuXi AppTec
Bill Harrison has over 30 years’ experience in the CRO industry with a strong record of growth. Prior to joining WuXi AppTec, he was founder and CEO of VIDA Sciences, a company serving CROs focusing on performance improvement. Earlier, Bill was President and COO of MPI Research... Read More →


Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 5&6

1:30pm PDT

Session B - Beyond Compliance Track
B-1  How the adoption of a quality management system can help the reproducibility and reliability of biomedical research: Oswaldo Cruz Foundation´s experience

Abstract:
In recent years, there has been increasing concern about the reproducibility and reliability of biomedical research. The lack of reproducibility in the research has a consequence from the non-confirmation of the results obtained with its attainment until rework and increase of costs. Recent studies indicate categories of errors that contribute to the irreproducibility of the research. These are: biological reagents, reference materials, research design, data analysis and laboratory protocols. The Oswaldo Cruz Foundation is a federal institution linked to the Brazilian Ministry of Health. Created in 1900, Fiocruz seeks to interconnect the fields of science, technology and health, conducting activities that include the development of research, provision of laboratory reference services, as well as, manufacturing of vaccines and drugs.  There are currently 271 research lines underway at the institution where about 1.500 research projects are developed. Since there are no international applicable standards and/or regulations documents that guide the adoption of good practices in research, Fiocruz has adopted two documents: the published by the World Health Organization entitled Handbook: Quality Practices in Basic Biomedical Research and the published by the São Paulo Research Foundation entitled Code of Good Scientific Practice. These documents include questions on quality policy and staff responsibility, physical resources, prescriptive and descriptive documents, a calibration and maintenance program for equipment among others. The adoption of these documents in Fiocruz is at an early stage, but there is already an improvement in the adoption of good practices, including document structuring, recording of activities and systematization of different practices.

Category:
University

Level of Content:
Intermediate

B-2 Tactical Questioning 


Abstract:
While the FDA, FBI, and other law enforcement are provided training in investigative interviewing, our industry QA professionals rarely have such training to assist them in conducting their roles including, but not limited to, performing audits and other quality assessments. This 90-minute session, led by a former FBI Special Agent William Vincent, will detail the most current interview and communication training which until recently was only available to government agents. It will address the reasons for the resurgence of the study of interviewing, as well as why the new research dispels some previously held beliefs regarding effective interviewing techniques. This training will introduce you to key practical takeaways to assist you in becoming a more successful interviewer as well as interviewee.Former FDA Investigator Laurie Taddonio and QA Consultant Robin Guy will join the panel to provide additional perspectives.

Category:
Other

Level of Content:
Intermediate

Speakers
avatar for Robin Guy

Robin Guy

GLP and Toxicology Consultant, Robin Guy Consulting, LLC
ROBIN C. GUY, M.S., D.A.B.T., RQAP-GLPRobin has been a toxicology and GLP consultant for the last 18 years for Robin Guy Consulting, LLC. Robin has extensive QA work experience involving administering GLP training courses (FDA, EPA, OECD), assisting labs with recommendations on how... Read More →
avatar for Renata Souza

Renata Souza

Oswaldo Cruz Foundation
Science and Technology Specialist from Oswaldo Cruz Foundation, acting as Quality Coordinator of the institution. Graduated in Biological Sciences with a doctorate in science and post-doctorate in the implementation of health quality management systems. Renata has training in the... Read More →
avatar for Laurie Taddonio

Laurie Taddonio

President, LMT Consulting LLC
LAURIE TADDONIO, LMT Consulting LLC: Laurie is an independent consultant with 25+ years of experience in the FDA-regulated industry, including 10 years with the FDA as a Bioresearch Monitoring Specialist Investigator, BIMO Program Manager, International Inspection Team member, and... Read More →
WV

William Vincent

Principle, G-Frog Consulting
Bill Vincent is a retired FBI Special Agent, former Police Officer and High Value Detainee Interrogation Group (HIG) interrogator/instructor. Bill spent 15 years working International Terrorism cases and 5 years assigned to the Central Intelligence Agency conducting human source... Read More →


Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 1&2

1:30pm PDT

Session C - I.T. Compliance Track
C-1 The Case of the Failing Pipette – A Case Study of Auditing in an Electronic Bioanalytical Laboratory

Abstract:
A common problem that every laboratory faces is when a pipette fails to meet the acceptance criteria during a re-calibration activity. The first question every auditor wants to know is:
What studies were impacted by using this pipette?
As an auditor, you are left reviewing laboratory notebooks. Was the pipette used by only one analyst? Which laboratory area utilized this pipette? The lingering question remains:
Did we find and document every study where this pipette was used?”
By using an electronic laboratory notebook to document every step in the workflow, from sample receipt through to final reporting, this pipette in question can be queried in minutes.
While auditing, a query can be ran to search any data held electronically within the electronic laboratory notebook (ELN). Queries can be as broad or as specific as the end user needs. This search would find in minutes what would normally take days or may even be impossible to locate. Audit trails can also be utilized to review the data and date/time the pipette was used. A thorough audit to determine where this pipette was used can be completed in just a few minutes.
Screenshots will be presented on the poster to show a query to search for the pipette used.

Category:
Bioanalytical

Level of Content:
Intermediate

C-2   Data Governance Best Practices for Bio-analytical Labs/studies

Abstract:
Bioanalytical sites performing regulated activities must incorporate key data integrity elements into their systems to ensure that all data are complete, consistent, and accurate throughout the data lifecycle. This presentation will focus on electronic data acquisition systems used for regulated bioanalysis. An overview of the configuration, validation, and maintenance of representative electronic data systems will be presented.  An audit program that includes provisions to evaluate the elements of the quality system used for collecting, analyzing, reporting and retaining information and bioanalytical data will be addressed. This presentation will provide Quality Assurance professionals involved in auditing bioanalytical data with insights to help assure electronic data integrity.

Category:
IT Compliance

Level of Content:
Advanced

Moderators
avatar for René Kasan

René Kasan

CEO, 37 Centigrades AG
René is a senior management consultant and subject matter expert for computerized systems in the pharmaceutical industry. In addition, he is founder and CEO of 37 Centigrades AG, a consultancy located in Zug, Switzerland with focus on providing IT-related services to the life science... Read More →

Speakers
avatar for Mohammed Imran

Mohammed Imran

Senior Quality Assurance Auditor, Smithers Avanza Biopharmaceutical Services
Mr. Imran has 20+ years working in regulated study environment and a MLS (ASCP)-licensed professional, starting as a research associate to QA in 1999. Responsible for performing quality assurance functions for the Bioanalytical Services Unit for non-clinical and clinical GLP/regulated... Read More →
avatar for Lucy Podbielski

Lucy Podbielski

Associate Director, Toxicology Lab Sciences QA, Charles River Laboratories
Lucy Podbielski is Associate Director, Toxicology Lab Sciences QA, Charles River. She has over 20 years of experience in bioanalytical labs, starting as an analyst and transitioning to QA in 2009. She manages the Toxicology Laboratory Science Good Laboratory Practice Quality Assurance... Read More →
avatar for Jasmine Roach

Jasmine Roach

Quality Assurance Specialist, AIT Bioscience
Ms. Roach is a Quality Assurance Specialist at AIT Bioscience located in Indianapolis, Indiana. She obtained a BS in Biology-Chemistry from Saint Joseph’s College as well as a BS in Nursing from Indiana University-Purdue University. Her earliest experience began at AIT Laboratories... Read More →
avatar for Kim Wheeler

Kim Wheeler

QA Manager, PPD
Ms. Wheeler started in GLPs in December of 1980 at A.H. Robins Research. She has over 10 years’ experience in analytical method development in GLPs /GMPs, having worked for Robins Research Division and Sergeant’s Pet Products.Kim Wheeler is a MLT-AD, ASCP, and managed a hospital... Read More →


Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 3&4

1:30pm PDT

Session D - GCP/PV Track

D-1  MHRA & FDA Pharmacovigilance Inspection Trends 

Abstract:
This presentation will provide information obtained for the most recent MHRA PV inspection metrics report and the data mining of the FDA warning letters and 483 with regard to PV reporting activities. A comparison will be made between the agency observation outcomes and trending over the last three available years with advice as to what audit areas should be focused on by PV auditors based on both regional and global expectations.

Category:
Pharmacovigilance

Level of Content:
Advanced

D-2   Demystifying Pharmacovigilance Auditing 

Abstract:
Word on the street is that Pharmacovigilance auditors are golden. This presentation will demystify PV auditing and explain the similarities and differences it has with the types of audits for which most QA professionals are familiar. Key elements of a PV audit will be shared along with advice and tips on how to apply existing QA knowledge and skills to PV auditing. There seems to be a shortage of quality assurance professionals with solid PV experience. A great number of QA auditors learned the tricks of our trade in clinical QA departments, spending a significant amount of time conducting investigator site audits. Many have spent entire careers in QA and not so much time in operational roles that provide on-the-ground, operational experience in various aspects of the drug development process, including PV.  Pharmacovigilance is a key piece of the drug development process that not only continues but picks up momentum after market approval. Following the rise of the European focus on quality systems and publication of the European Medicines Agency (EMA) GPV Modules, global attention on PV has escalated, causing Sponsors to turn to QA professionals for guidance. It's in the best interest of QA professionals to jump in and learn as much as possible about PV compliance and auditing so that we can meet the needs of our customers and enhance our ability to impact patient safety.

Category:
Pharmacovigilance

Level of Content:
Advanced

D-3  An Observation in Time Saves Nine 

Abstract:
Clinical research is a process driven activity.  Some processes are performed in parallel, some are performed in sequence; some intersect whereas others are independent of one another.  Whenever process steps are in sequence we have significant opportunities to identify up stream, high value critical control points that when used in risk based planning and auditing can:
  • reduce rework and corrective actions throughout the life of the trial,
  • enhance risk driven planning and “monitoring”,
  • provide a more efficient submission development process, and
  • ultimately contribute to regulatory confidence in patient safety and data integrity
As risk-based auditing becomes a more common area for consideration, situations that allow for identification of these high-value, critical control points should be factored into integrated risk plans and assessments, ensuring sufficient resources are devoted to their “monitoring” and evaluation.  At these critical control points, timely, high-value observations are like templates: you identify errors early and quickly, and the entire trial can benefit.  The trial maintains a potentially otherwise unrealized uniformity and consistency.
Technology provides us with the tools for attaining such uniformity.  But it is not the tools per se, it is the thought processes of those who recognize the nature of particular negative risk outcomes stemming from a particular critical control point that can make the difference between efficient clinical research infrastructure and electronic window dressing.
Examples will be provided from database development, data management and clinical monitoring can prevent errors from occurring and multiplying across a trial.

Category:
Good Clinical Practices

Level of Content:
Advanced

Moderators
MN

Milind Nadgouda

RiverArk Ltd.

Speakers
avatar for Dorcie Jasperse

Dorcie Jasperse

Raland Compliance Partners, LLC
Dr. Dorcie Jasperse has over 30 years of experience in clinical trials and medical research. Working in the government, academic, and commercial settings as a data manager, statistician and epidemiologist, project and program manager, GCP auditor, and manager of GMP auditors.In her... Read More →
avatar for Penelope Przekop

Penelope Przekop

CEO/Principal Consultant, PDC Quality Consulting
Penelope Przekop is an outcome-driven Senior Executive and Thought Leader with more than 25 years of success across the biotech, pharmaceutical, healthcare, teaching hospital, clinical trials, manufacturing, and design industries. Her broad areas of expertise include quality assurance... Read More →
avatar for Vaska Toné

Vaska Toné

CEO / Founder, LaVaPharm Consulting LLC
Vaska Tone is an independent international QA consultant and the founder of LaVaPharm Consutling with offices in the US and Europe. She has been in QA since 1994 performing global audits from GLP through to Post-Marketing PV audits. She is passionate about continual learning and speaks... Read More →
avatar for Miguel Zamora

Miguel Zamora

Pfizer
Miguel Angel Zamora is an accomplished, high-energy Director of Quality Operations with more than 20 year of global experience in a wide range of markets across biotech, pharmaceuticals, medical devices, cosmetics and manufacturing.His broad experience include Quality Management development... Read More →


Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 7&8

1:30pm PDT

Session E - Roundtables Track
E-1  QA for Today and Tomorrow - Challenging the Status Quo to Create the Future of QA

Abstract:
QA Professionals have the ability to impact quality in many different ways. Our role in interpreting, developing and applying standards and best practices is forever evolving.  This  interactive session will provide an opportunity for all QA Professionals, regardless of how long they have been in QA, to discuss ways to re-define the ”QA Experience” of the future. QA Professionals will need to adapt to changing communication methods and styles to meet the needs of their customers, whether internal or external stakeholders. We will spend the first part of the session discussing current thinking and challenge the status quo of ‘We have always done it that way so that is that is how we will do it now’.   The second part of the session will include 2 panels – one will be a panel of representatives with many years of varying QA experience and the other will be a panel of newcomers to industry. These panels will provide their perspective on issues currently facing the QA Professional, expected future challenges, and engagement of new people into this profession. We will discuss ways to incorporate existing and new ideas on how to address these areas.  QA will always be a profession where we are rewarded for our expertise – let’s help each other figure out to how continue that today and tomorrow.  

Category:
Beyond Compliance

Level of Content:
Basic

Moderators
avatar for Cheryl McCarthy

Cheryl McCarthy

Associate Director, Biogen
Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director... Read More →

Speakers
avatar for Jacqueline Bushong

Jacqueline Bushong

Director, CQA, Atara Biotherapeutics
Jacqueline (Jackie) Bushong RQAP-GCP, is the Director / Head of Clinical Quality Assurance at Atara Biopharmaceuticals in Westlake Village, CA. She has 20+ years of experience in pharmaceutical/biotech industry in the CQA profession. Previous employers include Kythera, Amgen, Chiron... Read More →


Tuesday April 10, 2018 1:30pm - 3:00pm PDT
Platinum 9&10

3:00pm PDT

Networking Beverage and Snack Break with Exhibitors and Posters (*Attended Posters*)
Assorted Cookies
Assorted Soft Drinks (Pepsi Products) Bottled Water
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Posters will be attended by their authors during this session. To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website.

Tuesday April 10, 2018 3:00pm - 3:30pm PDT
Marquis Ballroom

3:30pm PDT

Session F- GLP Track

F-1  EPA Regulatory Update 

F-2  Quality assurance auditing of analytical data in support of GMO crops development and production 

Abstract:
A genetically modified organism (GMO) has been produced by genetic engineering techniques.  Its genetic material has been altered to express one or more genes for novelty traits.  A common application of GMOs is in the agriculture and food industry where transgenic crops may offer selective advantages, such as resistance to insects or pathogens, herbicide tolerance, higher yields and increased nutritional values.  GMO testing laboratories develop and validate specific methods to fit the purpose of measuring certain new characteristics in diverse and complex plant matrices.  From a quality perspective, data should meet the well-known requirements of integrity, reproducibility, repeatability, accuracy, specificity, and traceability.  Quality assurance faces the new challenge to define and implement procedures to ensure that the measured analytical attributes are representative of specific transgenic events.  Compared to an environmental residue analysis, a typical auditing process for analytical GMO studies requires management of an increased amount of data complexity and variability.  Quality assurance auditing needs to verify that a standardized data interpretation is applied, so that the data produced is a consistent indicator of the genetic novelty.  A reliable quality system should include performance checks and indicators to guarantee that the overall GMO crop development and production process does meet current quality standards.  This presentation reviews the key aspects of auditing data measuring attributes in genetically modified crops and underlines how data quality translates into product quality.

Category:
Bioanalytical

Level of Content:
Advanced

Moderators
EH

Eva Haszcz

Gloabal Quality Programs Manager, FMC Corporation, Agricultural Solutions
Ms Haszcz has 17 years of experience working in GLP and GMP regulated environments. Since 2009 she is the Global Quality Programs Manager within the Regulatory Department at FMC Corporation. Through her work in a global regulatory setting she has gained an extensive understanding... Read More →

Speakers
avatar for Laura Ricci Daye

Laura Ricci Daye

Quality Assurance Auditor, knoell USA, LLC
Laura Ricci Daye is a Quality Assurance Auditor at knoell USA in the Research Triangle Park in North Carolina. Laura earned her MS in Molecular Biology from the Third University of Rome with a thesis work on the characterization of Nicotiana tabacum and Arabidopsis thaliana transgenic... Read More →
ML

Mark Lehr

EPA
Mark Lehr entered the environmental industry working as an environmental consultant. He conducted technical and scientific work related to Resource Conservation and Recovery Act (RCRA) permitted facilities and various National Priorities List (NPL) sites which included performing... Read More →


Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 5&6

3:30pm PDT

Session G - Beyond Compliance Track
G-1 Topic  Making it Real: Strategy to Execution, CPI

Abstract: Successful Continuous Improvement Programs are fundementally based in the ability to select projects which will move the organization to a goal.  One of the greatest challenges of successfull programs is the ability to align projects to a strategic objective.  This presentation will discuss project selection activities and behaviors which will align to business strategy to better insure CPI program success in achieving business outcomes and goals; Strategy to Execution.

Category: Beyond Compliance

Level of Content: Basic

G-2  An Introduction to Failure Modes and Effects Analysis (FMEA)

Abstract:
Are you reviewing the causes, effects and risks of systems or process failures? Do you need a tools that lets you identify what can go wrong, what’s the impact of it going wrong; and then if it’s important enough, what actions you need to undertake to make sure it doesn’t go wrong in the first place?  This session will introduce the Failure Modes and Effects Analysis (FMEA) tool and how to use it.

Category:
Beyond Compliance

Level of Content:
Basic

G-3  Quality Metrics: What and How to Measure for Effectiveness

Abstract:
Quality Metrics measurements are becoming a key issues in quality improvement processes.  What you are measuring may be effective or ineffective depending on the potential of an improvment.  How you measure for effectiveness will identify goals to achieve and whether the final outcome provides a potential for improvement.  The proper measurements will communicate values and priorities to an organization.
Some organizations are not sure why they may not get repeat customers or even new customers, which can be based on word of mouth.  Improvement processes by measuring the value metric and the proper measurement will encourage the customer to return.  This is part of the Customer Satisfaction metric.
This abstract will provide potential types of metrics and ways to measure these items for effectiveness.  The abstract will also provide examples of how the evaluations provide success stories.

Category:
Beyond Compliance

Level of Content:
Basic

Speakers
DA

Dave Asher

Asher Associates, Inc.
David Asher is a proven business leader with more than 20 years experience in business process improvements within Life Sciences R&D.  He has successfully lead deployments integrating Lean Six Sigma into transactional organizations.  David has trained, coached and developed hundreds... Read More →
avatar for JoAnn Boyd

JoAnn Boyd

Quality Manager, Southwest Research Institute
Jo Ann Boyd, BS/MBA, is quality assurance manager for Southwest Research Institute (SwRI) Chemistry & Chemical Engineering Division (C&CED). Ms. Boyd has Lead Auditor training for ISO 9001, ISO/IEC 17025,17020, and NQA-1 requirements with extensive experience establishing quality... Read More →
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →


Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 1&2

3:30pm PDT

Session H - I.T. Compliance Track
H-1  The Role of Metadata and Audit Trails in Ensuring Data Integrity 

Abstract:
Audit trails and other metadata are rightfully given significant attention in regards to their ability to explain data and support its integrity. These records are generated by computerized systems and tell the story about how the data was collected and used. However, systems used in GxP regulated activities generate audit trails that span the spectrum in regards to their content, organization, and usefulness. They can range from meeting the bare minimum of regulatory requirements (or maybe less) to recording nearly every keystroke.  This session will explore the role of metadata in the data lifecycle and how it can be used to evaluate data for integrity. In addition, approaches towards reviewing metadata and audit trails will be discussed in order to more efficiently and effectively use these records.

Category:
IT Compliance

Level of Content:
Intermediate

H-2   SEND – from zero to a converted (outsourced) study – a case study 

Abstract:
The requirements to submit non-clinical data using the SEND standard are here and in force.
Guidance for business process implementation has been scarce and we’ve all been learning as we go.
This presentation explains the process that was followed by one company to be in a position to confidently provide a SEND converted study to a sponsor in a timely fashion.
We will walk through the process from the rationale to outsource, supplier selection, pilot tests through to a completed study and all the steps in-between.

Category:
IT Compliance

Level of Content:
Intermediate

H-3  What you need to know about GDPR! 

Abstract:
The EU GDPR will go into effect in May 2018 and will require businesses to focus on identifying and protecting sensitive personal data of EU Citizens. In this session, we will share practical insights for what, as a quality assurance professional, need to know about the regulation and what to look at during an audit to improve data governance, reduce the risk of data loss and ensure compliance.
We will discuss the following Points as they relate to the EU data protection regulation:
-The role of data classification in protecting critical data assets.
-Data security.
-Transfer of data outside the EU.
-Pseudonymizing / anonymization.
-Joint Controllers
-Data Protection Officer (DPO)

Category:
IT Compliance

Level of Content:
Basic

Moderators
avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →

Speakers
avatar for Vince D'Angelo

Vince D'Angelo

VP Global QA, Instem
Vince D’Angelo FRQA has worked in the pharmaceutical software industry for over 30 years, including over 20 years’ experience in Computer Systems Validation and is currently VP Global Quality Assurance at Instem plc, who provide pre-clinical and clinical software solutions as... Read More →
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Matt Hansen

Matt Hansen

Covance
Matt Hansen is the Senior Manager of R&D Labs Global QA Support at Covance and is responsible for providing quality assurance oversight for computer systems and electronic records. Mr. Hansen has over 12 years of QA experience in GxP environments, much of that time focusing on compliance... Read More →
avatar for Joanne Tyas

Joanne Tyas

Director Quality Assurance, ITR Laboratories Canada Inc.
Joanne Tyas is the Director of Quality Assurance at ITR Laboratories, a pre-clinical contract research organization in Canada. She has over 22 years of experience of working in a GLP environment. Throughout her career Joanne has worked on multiple computer validation projects and... Read More →


Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 3&4

3:30pm PDT

Session I - GCP/PV Track
I-1   The Trials and Tribulations of Getting Multiple Laboratories at Multiple Sites to Work as One Cohesive Unit 

Abstract:
If you’re going to bring multiple laboratories of different types and in different locations with different areas of expertise and different quality systems and merge them all into one big happy family to support a high-profile clinical study, you can expect to be faced with significant challenges.  Our lab has done just that and would like to share some of our experiences over the last 3 years of this collaborative effort.  The most significant challenges from the start were (1) developing and implementing a single assay procedure that could be used at any site and obtain consistent and comparable results between sites over an extended period of time, (2) creating and managing a harmonized quality component that would complement but not impede existing  or proprietary systems and procedures, (3) dealing with multiple regulatory applications and expectations based on the nature of the assay, types of laboratories, and requirements of the clinical trial, (4) coordination of specimen handling between sites,  and (5) dealing with a research mentality in a regulated world.  By necessity the various labs had to have some commonalities, which we were able to leverage to our advantage.  But different systems and different perceptions of what needed to be done more often than not created a few speed-bumps – and sometime big potholes - in the road to success.  This presentation will discuss some of the most significant challenges we faced and how we successfully met and resolved them.

Category:
Good Clinical Practices

Level of Content:
Advanced

I-2  How to Make Your FDA Inspection Efficient and Painless

Abstract:
Everybody in the clinical arena; Sponsors, CROs, Clinical Investigators and their staff and all others) fear FDA inspections.  In this presentation I will describe how to make your Regulatory Inspection Efficient and Painless.  This presentation is excellent for all Sponsor Company's, CRO, Auditor's and contract auditros who will be tasked to prepare clinical investigator sites for potential FDA inspections.  During this training, the following topics and points to consider will be covered in depth to help prepare for FDA inspections.
-Describe the FDA Clinical Investigator Inspections
-Describe the inspection process (FDA BIMO Manual)
-FDA Inspection preparation
-Behaviors during the inspection (Do's and Dont's)
-How to respond to FDA questions
-Discuss common inspectional observations and how to respond to them
-Provide FDA metrics from previous year for Clinical Investigator's, IRB's and Sponsor Inspections
-Most common Clinical Investigator deficiencies will be discussed
-Recap

I developed this presentation and it has been used in 2017 to prepare 14 Clinical Investigator sites in both US and EU as part of my company's FDA Readiness Training Preparation.  This has been well received at all sites and many positive learning experiences have taken place.  This training provides key tips on how to be fully prepared to handle FDA inspections.  With a little training and alot of preparation, most clinical sites can be fully prepared to face the FDA when they visit .  

Category:
Good Clinical Practices

Level of Content:
Advanced

Speakers
avatar for Pamela Barry

Pamela Barry

Associate Director, Quality GCP, Acorda Therapeutics
Pam has been an active member of SQA since the nearly 90’s and was a founding member in developing the GCP section at SQA.She is the Associate Director of Quality Assurance GCP for Acorda Therapeutics in Ardsley, NY and has been in various roles within QA her entire career of 35... Read More →
PR

Patty Runge

Molecular Characterization Laboratory, Frederick National Laboratory for Cancer Research
Patty Runge has been active in the Quality Assurance arena for more years than she would like to admit, starting at Covance (when it was still Hazleton Laboratories), Experimental Pathology Laboratories and EPL Archives, Human Genome Sciences, and currently as QA Manager at the Molecular... Read More →


Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 7&8

3:30pm PDT

Session J - Roundtables Track
J-1   Medical Device Test Article Characterization - Sponsor and CRO Perspective 

Abstract:
Medical devices run the gamut from single materials to composite materials, may include different functional components, be combination products, electronic devices, and may have associated software.  With all this variation, how do you meet the requirements of §58.105, clearly identify what is being tested and have sufficient documentation to prove it.  This session will present best practices to achieve compliance for test article characterization for the various types of medical devices that are currently available.  Best practices will be discussed from the perspective of the CRO and sponsor.

Category:
Medical Device

Level of Content:
Advanced


Moderators
avatar for Debra Bridges

Debra Bridges

GLP Consulting Services
Debra Bridges is President of GLP Consulting Services and former Associate Director of Operations and Regulatory Compliance for the Texas A&M Institute for Preclinical Studies. She has over 25 years of quality assurance, regulatory compliance, and combined research experience in industry... Read More →

Speakers
avatar for Hector Gamboa

Hector Gamboa

Sr. Quality Audit Specialist, Abbott
Hector Gamboa is Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP). He was the 2016 President of the Pacific Regional Chapter of the SQA (PRCSQA) and he currently serves as a member of the Board of Directors at the Society of Quality Assurance (SQA... Read More →
FR

Felice Randi LaMadeleine

Manager - Quality Assurance, Toxikon Corporation
Ms. LaMadeleine has over 25 years of experience in the medical device, pharmaceutical, industrial chemistry, and biotech industry, with the last 16 years in Quality Assurance. She joined Toxikon Corporation as a Data Reviewer/Auditor in 2000, then became a Quality Assurance Officer... Read More →


Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 9&10

5:00pm PDT

Animal Health Specialty Section (AHSS)
There will be a peripheral meeting of the Animal Health Specialty Section.  We will be discussing recent inspectional experiences, the status of our EDC subcommittee, and having open discussions on a number of topics.  We have also invited individuals from regulatory agencies to answer questions and address hot topics.

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
Orange County 4

5:00pm PDT

BioAnalytical Specialty Section (BASS)
Greetings to all fellow SQA members!  Want to know more about BASS? The BioAnalytical Specialty Section (BASS) serves as a network resource for QA professionals addressing regulatory compliance questions as applied to GxP bioanalytical testing.  All are welcome.  Please join us to learn more!

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
Gold Key III

5:00pm PDT

Computer Validation Initiative Committee (CVIC)
As announced during the Opening Plenary Presidential Address, CVIC has rebranded and restructured itself to better meet SQA member needs. Interested in hearing more about the 'new' CVIC and how you might fit in?  Please join our specialty section meeting where you can meet the current CVIC team, learn about our new model & subcommittee structure, and most importantly – learn about the greater opportunities for YOU to become involved!    

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
Platinum 1&2

5:00pm PDT

EPA Subcommittee of the GLP Specialty Section
Please join with your fellow SQA QAU Professionals for a Q&A session with an EPA regulator, and discussion of current GLP topics.  This is a great opportunity to engage in discussion with EPA and with others on important issues and challenges in our QA profession. All are welcome!

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
Platinum 3&4

5:00pm PDT

Medical Device Specialty Section (MDSS)
Please join the Medical Device Specialty Section for a meet and greet and round table discussion of GLP medical device challenges.

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
Orange County 3

5:00pm PDT

5:00pm PDT

Pharmacovigilance Specialty Section (PVSS)
The purpose of QACS is to focus on the development, promotion and dissemination of information, ideas and standards surrounding the business requirements and demands of being or becoming an independent consultant. Everyone interested in QACS is welcome to attend.

Tuesday April 10, 2018 5:00pm - 6:30pm PDT
San Diego, Lower Level

5:00pm PDT

6:00pm PDT

Quality Assurance Consulting Support Specialty Section (QACS)
The purpose of QACS is to focus on the development, promotion and dissemination of information, ideas and standards surrounding the business requirements and demands of being or becoming an independent consultant. Everyone interested in QACS is welcome to attend.

Tuesday April 10, 2018 6:00pm - 7:00pm PDT
La Jolla/Los Angeles, Lower Level

6:00pm PDT

North Carolina Chapter of SQA (NCCSQA)
The North Carolina Chapter of SQA (NCCSQA) is hosting a reception for chapter members and friends on Tuesday, April 10th from 6:00-8:00 PM at McFadden's Restaurant and Saloon (400 W Disney Way, Anaheim, CA - a short walk from the Anaheim Marriott).  Please stop by to say hello to NCCSQA Executive Council members, play outdoor games on the patio, meet some new folks, and learn more about this active chapter!  Appetizers and adult beverages will be served.

Tuesday April 10, 2018 6:00pm - 8:00pm PDT
McFadden's Restaurant and Saloon

6:30pm PDT

Happy Hour Featuring The Deviations
Complimentary for all SQA Annual Meeting attendees!
Join us for this networking opportunity in a relaxed atmosphere with music provided by the SQA house band, the Deviations. Come on down and feel free to jam with the band!

Tuesday April 10, 2018 6:30pm - 8:00pm PDT
Orange County 1&2
 
Wednesday, April 11
 

7:30am PDT

Continental Breakfast with Exhibitors and Posters
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Assorted Muffins
Served with Preserves, Butter
Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Egg White Scramble with Vegetables
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Wednesday April 11, 2018 7:30am - 8:30am PDT
Marquis Ballroom

7:30am PDT

Council on Professional Registration RQAP Recognition Breakfast
Join the Council on Professional Registration for breakfast in honor of all meeting attendees who are Registered Quality Assurance Professionals. Pick up a ribbon for your name tag to identify you as a successful RQAP recipient and show that you value this achievement. Future plans for the RQAP program will be announced, and ways you can become involved in the process will be presented. In addition, Council members will answer any questions you may have about the program.

Wednesday April 11, 2018 7:30am - 8:30am PDT
Gold Key I&II

7:30am PDT

GLP Specialty Section (GLPSS) Breakfast
Please join with your fellow SQA QAU Professionals to discuss the most current GLP subjects.  Invited agency regulators may also provide insights to pressing topics relevant to industry.  This is a terrific opportunity to develop professional relationships with fellow GLP SS members.

Wednesday April 11, 2018 7:30am - 8:30am PDT
La Jolla/Los Angeles, Lower Level

7:30am PDT

Registration Desk Open
Wednesday April 11, 2018 7:30am - 5:00pm PDT
Platinum Registration

8:30am PDT

Session K - GLP Track
K-1  Inspections in China

Abstract: TBA

Category: 
TBA

Level of Content
TBA

K-2 Bias Control: Protecting Us from Ourselves

Abstract: Not too long ago, Francis Bacon issued his philosophical work entitled, Novum Organum Scientiarum (‘new instrument of science’). It continued our understanding of the scientific method by focusing on empirical investigation. He noted that as humans we are programmed to pay more attention to evidence that agrees with our preconceptions and to reject evidence that doesn’t. If we want to learn more about the universe, we needed to take this inherent tendency toward natural bias into consideration in the design of scientific experimentation and focus on empirical investigation. It’s been 400 years since Novum Organum and we still struggle with preventing non-random error from influencing research planning, conduct, analysis and reporting. This presentation will explore potential sources of error and bias in experimental research, will review some of the real dangers of research bias, and present common methods for controlling for bias within GLP studies.

Category:
Good Laboratory Practices

Level of Content:
TBA

Moderators
avatar for Deborah Parker

Deborah Parker

QA Manager, ICON Bioanalytical Laboratories
Deborah Parker is a QA Manager at ICON PLC. She has over three decades of experience in the pharmaceutical industry, with training as a bioanalytical scientist. Having performed analysis using RIAs, Enzyme Inhibition testing, ELISAs, HPLC and LC-MS/MS, her background provided a perfect... Read More →

Speakers
avatar for Cat Bens

Cat Bens

Colorado State University
Catherine Bens is the Quality Assurance Manager within the Research Integrity and Compliance Review Office at Colorado State University and provides quality assurance oversight for a wide variety of regulated research, including non-clinical and clinical studies and manufacturing... Read More →
avatar for JoAnn Boyd

JoAnn Boyd

Quality Manager, Southwest Research Institute
Jo Ann Boyd, BS/MBA, is quality assurance manager for Southwest Research Institute (SwRI) Chemistry & Chemical Engineering Division (C&CED). Ms. Boyd has Lead Auditor training for ISO 9001, ISO/IEC 17025,17020, and NQA-1 requirements with extensive experience establishing quality... Read More →


Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 5&6

8:30am PDT

Session L - GMP Track
L-1  Achieving a “Culture of Quality” in a GMP CRO/CMO environment

Abstract:
A Quality Management System (QMS) incorporates the systems and processes by which regulated activities are performed. Training provides the skills and capabilities to deliver against QMS requirements. However, without the correct attitudes and behaviours instilled in those who operate within the QMS, it is unlikely that any organisation will deliver against its regulatory obligations and customer expectations.
Implementation of a “Quality Culture” in a highly regulated industry is challenging, but also very rewarding.  Drawing on our own experiences, this session will discuss the benefits of implementing the right “ Quality Culture”, along with the behaviors and actions critical to maximizing the potential rewards.

Category:
Good Manufacturing Practices

Level of Content:
Basic

L-2  Failure to Investigate


Abstract:
To this day, "failure to thoroughly investigate," is still cited by the FDA in warning letters making the need for thorough investigations crucial for cGMP facilities.  In 2016 this finding ranked number 3 on the FDA”s list of drug inspectional observations summary.  This session is intended to review the FDA's OOS Guidance Document and possible things to consider when conducting an investigation to ensure failures are thoroughly investigated.  

Category:
Good Manufacturing Practices

Level of Content:
Basic

L-3  Aligning Security with Partner Engagement Models for Greater Quality Oversight 


Abstract:
With outsourcing of critical functions, maintaining quality oversight is critical. Audits alone are no longer sufficient and many companies are demanding ongoing data and content from partners that include stability tests, batch records, deviation and investigation reports, and CAPAs.
Companies are also sending official procedures and documents to partners – in the form of contractor manuals – that must stay current. Updates received by partners need to be acknowledged and often require additional information such as implementation date. Current methods of using email, file shares, and phone calls do provide an audit trail of who sent, reviewed, or accepted the information – creating compliance risks and eroding data integrity.
Incorporating partners into processes with modern applications provides a scalable, seamless experience for both parties that can be tracked and easily monitored. With a wide range of partner engagement models, security plays a fundamental role in the technology. Learn how pharmaceutical companies are collaborating with contract organizations and how security is setup to ensure information is securely shared between both parties. We will also discuss:
-Different partnership models, challenges, and benefits
Security requirements for each model and how technology can meet those needs
-How to leverage security and controlled workflows to reinforce roles and responsibilities and prevent partners from accessing each other’s information
-How to operationalize lot release process, stability test review, technology transfer, and contractor manuals
-Sample workflows with contract manufacturing organizations (CMOs) and test labs (CTLs)
-How security will evolve in the next 3-5 years to meet outsourcing demands

Category:
Good Manufacturing Practices

Level of Content:
Advanced

Moderators
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →

Speakers
avatar for Reed Bailey

Reed Bailey

Covance Laboratories
As a quality leader for Covance,Sr. GMP QA Manager for North America Covance,  I manage the GMP Quality Assurance team that supports analytical testing for clinical and commerical batch release as well as the GMP batch release for early Phase clinical studies.  Prior to my role... Read More →
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →
avatar for Sandeep Chopra

Sandeep Chopra

VP Product Management, Veeva Systems
Sandeep has over ten years of experience developing security products and providing security services. At Veeva, he was responsible for Vault platform security before becoming VP of product management for the Vault Quality Suite. Sandeep previously led product teams at Deloitte, MobileIron... Read More →


Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 1&2

8:30am PDT

Session M - I.T. Compliance Track
M-1  FDA & Industry: The Patient Will See You Now!!

Abstract:
The New Health Economy requires that pharmaceutical and life sciences companies and their chief regulator the Food and Drug Administration, collaborate to meet 21st century demands which are seeing much more sophisticated & informed Patients (consumers). Executives and regulators should seize upon this momentum to build closer relationships and facilitate more meaningful communications around product development and review. A greater reliance on public private partnerships could also provide a forum for the exchange of ideas.
This presentation will describe the ultimate consumer, the Patient, and discuss patient expectations for 21st century health care. It will then present a case for closer collaboration and mutual training between FDA and industry to ensure America’s perch as a global leader in medical innovation and to stimulate the next generation of treatments and cures and  meet patient needs. FDA has already started such a program. This presentation it will give the latest information on existing collaboration efforts between FDA and industry and their benefit and will present ways to further strengthen the relationship between the two to serve the Patient.

Category:
Other

Level of Content:
Intermediate

M-2  Cyber Security & Business Continuity in the Cloud


Abstract:
When it comes to cyber security and the thread of being attacked, it's a matter of "when" and not "if". If you're plugged in then you're vulnerable, and if you're vulnerable hackers are already looking for you.  For Life Science companies this is especially challenging because regulation requires your systems be secure and readliy available for consistent intended performance.  Not only must they be secure, you must also be able to recover in the event of a disaster, including catestrophic disasters.  One may think the best solution is to maintain control of all computer servers, protecting the equipent inside a physical fortress that is enhanced with virtually inpenetrable logical shields.  That sounds good but the biggest problem here is what's already inside your walls.  This presentation will identify the threats we face regarding cyber security, and measures we can take to mitigate them.  The challenges we face with business continuity, and how to conquer them.  Finally, the fear we face with cloud-based solutions, and how to overcome them.  Attendees will walk away with a better understaning and a high-level plan of action they can take back to their organization to begin strengthing the company's defense mechanisms, and leveraging technology to promptly recover in the even of a disaster, including the use of cloud based technologies.  

Category:
IT Compliance

Level of Content:
Advanced 

Moderators
Speakers
AB

Angela Bazigos

Touchstone Technologies, Inc.
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has 40 years of experience in the Life Sciences & Healthcare Industries. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science... Read More →
JK

Jane Kreis

U.S. Food & Drug Administration, Office of Regulatory Affairs, Pacific Region
avatar for Steven Thompson

Steven Thompson

Sr. Manager, Prof. Svcs., ValGenesis, Inc.
Just mention auditing, validation, CSV, technology, Artificial Intelligence / Machine Learning, cybersecurity, scuba diving, or animals (especially dogs & elephants) and we'll have a great conversation.


Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 3&4

8:30am PDT

Session N - GCP Track
N-1  QRM, GCP and Quality Assurance - Building Quality into Clinical Trials

Abstract:
The adoption of ICH E6 R2 in the EU has created an interesting and challenging opportunity for the overall systems assuring quality in research; specifically, the application of Quality Risk Management (QRM) to GCP. QA professionals are an integral part of the overal quality assurance system. The QA role continues to evolve and expand as many QA departments assume more responsibility in addition to auditing - oversight of "CAPA" programs, Inspection readiness. This session will provide lessons learned from years of GMP application of QRM and QbD to GCP service quality and highlight the challenging opportunity for QA to support QRM in GCP.

Category:
Good Clinical Practices

Level of Content:
Advanced

N-2  GCP Compliance and Audits in a Risk-Based Environment 

Abstract:
A formal program for GCP Compliance has become an integral means for meeting global regulatory expectations for clinical trial quality and as an integral part of a clinical Quality Management System approach. The advent of risk based approach to monitoring and agency’s risk based inspection program means that sponsors should be employing risk based audits as well to assure quality.  A robust CAPA (Corrective and Preventative Actions) process is also an essential component of a company’s Quality System to document that the actions taken to correct and to prevent the nonconformance were effective.   Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with Good Clinical Practice expectations. Participants will also learn about the considerations for non compliance and the types of findings in an audit that can lead to regulatory problems.  This presentation will examine risk based auditing and how this approach can be implemented in your organization to assure quality data.

Category:
Good Clinical Practices

Level of Content:
Intermediate

N-3 Risk-Based Audit Program Planning : GCP System Audits

Abstract:
The goal of system audits is to establish that core clinical research processes are compliant with ICH guidelines, applicable local regulations and company policies and procedures, regardless of the priority level of the research being conducted. System audits allow an organization to leverage risk across  all therapeutic areas and research activity without having to touch every trial at any given time. A risk-based approach is more likely to ensure subject protection and overall study data integrity and allows sponsors to focus compliance efforts more efficiently. In this session, we will cover quality risk management concepts and explore ways to implement these concepts utilizing a risk-based approach for a GCP system audit program/plan.

Category:
Good Clinical Practices

Level of Content:
Intermediate

Moderators
avatar for Penelope Przekop

Penelope Przekop

CEO/Principal Consultant, PDC Quality Consulting
Penelope Przekop is an outcome-driven Senior Executive and Thought Leader with more than 25 years of success across the biotech, pharmaceutical, healthcare, teaching hospital, clinical trials, manufacturing, and design industries. Her broad areas of expertise include quality assurance... Read More →

Speakers
LC

Liziel Concepcion

Allergan
Liziel Concepcion, RQAP-GCP is Manager of R&D Clinical Quality at Allergan in Irvine, CA. She has led both directed and routine investigator site audits, service provider audits and system audits. She has cross-trained in GLP and CSV disciplines, resulting in her leading audits in... Read More →
avatar for Michael Hamrell

Michael Hamrell

MORIAH Consultants
Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA.  He has worked in drug development, clinical research and regulatory affairs for over 30 years.  Dr. Hamrell has a Ph.D. degree in Pharmacology... Read More →
avatar for Eric Humes

Eric Humes

Executive Director, QA, Medpace
Eric Humes is Executive Director, Quality Assurance at Medpace. Medpace is a full-service global contract research organization providing drug, biological and medical device development expertise from test-tube to marketing approval. Mr. Humes has a broad range of industry experience... Read More →


Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 7&8

8:30am PDT

Session O - Roundtables Track
O-1   Supporting the Medical Device Single Audit Program (MDSAP): The Role of the CRO

Abstract:
A global approach to auditing and monitoring the manufacturing of medical devices has been developed from an international coalition between the United States, Australia, Brazil, Canada and Japan. This international consortium, Medical Device Single Audit Program (MDSAP) became fully operational in 2017. Starting the 1st of January 2019, MDSAP will be the only certification accepted by Health Canada. The Canadian MDSAP transition period corresponds closely with the transition period for the revision of ISO 13485. With MDSAPS full implementation on the horizon, time is flying by.
MDSAP allows medical device manufacturers the opportunity to achieve and maintain regulatory compliance, including the consortium countries, with a single audit certification. The MDSAP audit report has bene accepted as a substitute for routine Agency inspections. The audit, based on ISO 13485 and 14155, requires a preparation period to ensure compliance to the MDSAP guidance.
Due to the nature of our CRO business, we have diverse clientele and offer practical and customized services with an expertise in medical device clinical research. As international regulations evolve, our team is undergoing a global effort to establish best practices to accommodate and preemptively maintain compliance.  Key factors to consider for proactive implementation:
·        Contracts designed in compliance with the guide prior to certification
·        3rd Party Auditing Organizations scheduling, expect delays and forced prioritization
·        Effects of BREXIT, have a contingency plan
·        EU MDR/IVDR timeline early 2020, extends the QMS adaption timelines
·        Re-designation of Notified Bodies, anticipate more demand of and from Notified Bodies
·        Post-audit time frames, e.g., nonconformities etc.

Category:
Medical Device

Level of Content:
Intermediate 

Speakers
avatar for Bethany Davis

Bethany Davis

Clinlogix
Bethany has over twelve (12) years of experience in the pharmaceutical and research industry. Before joining Clinlogix, Bethany’s experience includes McNeil Consumer Healthcare, Dr. Reddy’s Laboratories and The Commonwealth Medical College.  Bethany has designed and implemented... Read More →


Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 9&10

10:00am PDT

Networking Break with Exhibitors and Posters
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Wednesday April 11, 2018 10:00am - 10:30am PDT
Marquis Ballroom

10:30am PDT

Session P - GLP Track
P-1  QAU Report to Management: How Do You Make QA Audit Findings Relevant?

Abstract: TBA

Category: TBA

Level of Content: TBA

P-2  BIMO Inspections Update

Abstract: TBA

Category: GLP

Level of Content: Beginner to Advanced

Moderators
avatar for Megan Lawhead

Megan Lawhead

Charles River Laboratories
Megan Lawhead is the Quality Assurance Supervisor at Charles River Horsham. She has been with Charles River for over 10 years. She is the current MARSQA President. Megan has a Bachelor’s Degree in Psychology from West Chester University and a Master’s degree in Biopsychology from... Read More →

Speakers
AJ

Anne Johnson

Division Director, BIMO East, District Director PHI-DO, U.S. Food & Drug Administration
Anne E. Johnson is the District Director of FDA’s PHI-DO and the Program Division Director of OBIMO Division 1 (East).  As the District Director, she is the most senior FDA representative and point of contact for the states of Pennsylvania and Delaware.  In this capacity she remains... Read More →
avatar for Thomas Purdue

Thomas Purdue

QA Compliance Analyst V, Boehringer Ingelheim Pharmaceuticals, Inc
Mr. Purdue is a Registered Quality Assurance Professional in GLPs (RQAP-GLP) and has over 25 years of experience in performing GLP audits of facilities and studies to comply with U.S. FDA, EPA, European, and Japanese GLP regulations. He has 10 years’ experience in GMP Quality Assurance... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 5&6

10:30am PDT

Session Q - GMP Track
Q-1  Transforming Change Management with Modern Solutions

Abstract:
Continued growth in global outsourcing, greater regulatory scrutiny, and legacy systems has led to unprecedented levels of complexity for managing quality. Change management is often a cross-functional process with global stakeholders. However, with different tools across multiple departments, making intelligent decisions in a timely manner is difficult.
Efficiently assessing impact, orchestrating, and executing a change plan is critical. Some changes have regulatory impact ­­and require approval from each country’s health authority before shipping product. With extensive coordination needed between quality, manufacturing, and regulatory, companies need to effectively manage change while balancing inventory and product ship decisions.

Modern systems provide greater visibility and enable seamless processes between functional areas. Equipped with better intelligence and more efficient changes, companies decrease risk and achieve agile decision-making. In this presentation, you will learn how to transform change management, including:
• Providing a framework to systematically assess global operational and regulatory impact
• Guidance on roles and responsibilities across the change management process
• Streamlining processes between quality and regulatory departments, or QMS and content systems
• Facilitating efficient execution of multiple tasks for a change plan
• Structuring change releases and putting into effect in a global environment

Category:
Good Manufacturing Practices

Level of Content:
Advanced

Q-2  Execution of a proper event investigation


Abstract:  An article examining recent GMP inspection data from CDER and MHRA (Medicines and Healthcare Products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I admit I agree.  
During this presentation, we will discuss the reasons why executing a proper Event Investigation still seems to elude us and how to structure your compliance system to:
  • Standardize of the process for performing an Event Investigation, thereby eliminating inconsistencies in execution and documentation.
  • Capture the process in one procedure instead of several procedures resulting in a more streamlined management process.
  • Ease the training burden and promote greater compliance with dedicated focus and specificity on a process used by many employees.
We will also detail the process for navigating an Event Investigation, specifically:
  1. Describing the event
  2. Collecting the data
  3. Performing a root cause analysis (RCA)
  4. Performing impact and risk assessments
  5. Determining Corrective and Preventive Actions (CAPAs) and document changes
  6. Conclusions and Effectiveness Checks (ECs)
Category:
Good Manufacturing Practices

Level of Content:
Intermediate

Moderators
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →

Speakers
avatar for Judy Carmody

Judy Carmody

Founder and Principal, Carmody Quality Solutions
Judy Carmody, Ph.D., is the founder and Principal Consultant of Carmody Quality Solutions, LLC., a dynamic, innovative consulting agency that provides Quality services to the pharmaceutical, biologics and medical device industries. Dr. Carmody is the former president of Avatar Pharmaceutical... Read More →
avatar for Mike Jovanis

Mike Jovanis

Veeva Systems
Mike Jovanis is Veeva Systems’ Vice President of Vault Quality at Veeva Systems, and is an accomplished executive and recognized leader in the quality technology space. Over his decade-long career in the life sciences industry, he has proven instrumental in building Sparta Systems... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 1&2

10:30am PDT

Session R - I.T. Compliance Track
R-1  Server virtualization, cloud technology and impact to data integrity in regulated environments

Abstract: TBA

Category: TBA

Level of Content: TBA

R-2   Electronic Signatures and how to use them

Abstract:
This is a Case Study on how to obtain digital signatures to eliminate paper documentation.   To start with you must have a work process that is simple to use and eliminates redundancy.  Next, you need to understand the basics of obtaining a digital certificate and how it works.   Now that you have a digital certificate and before you can apply it to a document, that document must be properly prepared to accept the digital certificates.  One the key attributes is to allow multiple signatories the ability to sign a single document and a central site is needed for access, storage  or archive the documents.  Finally, you need to validate the process to Part 11.

Category:
IT Compliance

Level of Content:
Advanced 

Moderators
avatar for Mohammed Imran

Mohammed Imran

Senior Quality Assurance Auditor, Smithers Avanza Biopharmaceutical Services
Mr. Imran has 20+ years working in regulated study environment and a MLS (ASCP)-licensed professional, starting as a research associate to QA in 1999. Responsible for performing quality assurance functions for the Bioanalytical Services Unit for non-clinical and clinical GLP/regulated... Read More →

Speakers
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

FDA
Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She has extensive experience... Read More →
avatar for Patricia Miller

Patricia Miller

Sr. Mgr, QA IT, Global Quality Systems, Seqirus, Inc.
Ms. Patricia Miller is a Senior Manager of QA IT in the Global Quality Systems Group at Seqirus, Inc. in Holly Springs, NC, where she oversees the compliance and data integrity of regulated computerized systems across the entire company, including the R&D and manufacturing systems... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 3&4

10:30am PDT

Session S - GCP Track
S-1   How to select the most appropriate effectiveness check for your corrective action

Abstract:
Once a corrective action has been implemented, it is important to assess the success of the action to prevent reoccurring issues. This is activity is called an effectiveness check. The type of effectiveness check that one selects is depenendent on a number of factors such as complexity of the issue, the frequency of a particular activity occurs in the business, and the ability to measure the impact of the corrective action. In this presentation, different types of effectiveness checks will be discussed with examples along with their appropriateness for different types of corrective actions.

Category:
Good Clinical Practices

Level of Content:
Advanced

S-2  Implementing Real Quality Management in Virtual Companies: How to Master the Challenge


Abstract:
There are companies out there that function without a company office, with employees being internationally dispersed and working remotely. These organizations may consist of a handful of enthusiastic experts in their field that are providing services in a small niche. They function in a different manner than traditional organizations.
When such an organization is a CRO, clients often have doubts about the CRO's ability to comply with project and regulatory requirements, just because they are different and not a mirror of their own company. When asked to assist with the implementation of a Quality Management System for such a CRO, there are numerous aspects to consider to ensure the resulting system serves the CRO, but also convinces their clients and last, but not least, the regulatory authorities.
Can 'Real Quality' be achieved in a 'Virtual Organization'? The presentation will tell the story of the QMS development and implementation, the discussions around it, the challenges encountered (internally as well as with clients) and which solutions worked and which did not. Of course, as always, time was of the essence and the QMS needed to be ready within a couple of weeks. Which questions must be asked and answered, which documents be generated? What is vital to make a virtual organization prepared for client audits and inspections?
QMS are dynamic and of course, the QMS may be further enhanced or radically changed. Be courageous, but be also careful that the organization can digest the changes.

Category:
Good Clinical Practices

Level of Content:
Advanced

S-3 Quality by Design and its Impact on QA


Abstract:
With the advent of risk management and the quality management approach under Good Clinical Practice (GCP), among other new concepts, the principles of Quality by Design (QbD) has converged on the clinical arena and is impacting our daily work as QA professionals.  One area that is continually struggling is the development of an adequate robust product development plan, which among other areas includes protocol and trial development.  If the product development plan is not designed properly up-front, besides adding to errors, loss of productivity and increasing costs in clinical trial conduct, obtaining regulatory clearance/approval to market a given product can become a very difficult and time consuming task. In this age of quality management systems impacting the Clinical arena, more and more QA personnel are reporting they are being asked to step into roles that were not traditionally seen as QA roles.  This session will explore the impact of QbD on the QA role, provide an overview of what it entails, and provide some practical tips on how best to accommodate those requests without compromising QA.

Category:
Good Clinical Practices

Level of Content:
Intermediate 

Moderators
Speakers
RH

Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Leslie Sidor

Leslie Sidor

Senior Director Quality Risk Management, Biogen
Leslie is the Senior Director of Quality Risk Management in R&D Quality, Operations and Performance at Biogen where she is responsible for R&D’s Quality Management System. Prior to joining Biogen, she led the Global Quality Engineering team at Amgen where she was responsible for... Read More →
avatar for Lee Truax-Bellows

Lee Truax-Bellows

President, CRO, NCRA
Lee Truax Bellows, RQAP-GCP, CCRALee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a GCP Quality Auditor, Trainer, and Project Manager. Lee has been involved in regulated research for the past 28 years... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 7&8

10:30am PDT

Session T - Roundtables Track
T-1   Archiving Electronic Data – Black and White and Shades of Gray

​​​​Abstract:
Rapidly advancing technology seeking breakthroughs for treating diseases with medical devices, drugs, and combination products, requires access to  and increasing use of computerized systems in GLP studies. Data types run the gamut from proprietary software used for physiological monitoring,  advanced imaging systems data, clinical pathology data,  digital images (photographs and micrographs), and systems to collect comprehensive preclincal data sets just to name a few. The array of electronic data coupled with different system owners, server access limitations, varied data collection procedures, storage capacity, stability of media, and ability to read the data for the period required for retention are some of the challenges faced as electronic data becomes the norm. The Medical Device Specialty Section, Computer Validation Initiative Committee, and Scientific Archiving Specialty Section will discuss the issues and recommend best practices for archiving electronic data in compliance with 21 CFR Part 58 and Part 11.

Category:
Scientific Archiving

Level of Content:
Intermediate

Moderators
FR

Felice Randi LaMadeleine

Manager - Quality Assurance, Toxikon Corporation
Ms. LaMadeleine has over 25 years of experience in the medical device, pharmaceutical, industrial chemistry, and biotech industry, with the last 16 years in Quality Assurance. She joined Toxikon Corporation as a Data Reviewer/Auditor in 2000, then became a Quality Assurance Officer... Read More →

Speakers
avatar for Debra Bridges

Debra Bridges

GLP Consulting Services
Debra Bridges is President of GLP Consulting Services and former Associate Director of Operations and Regulatory Compliance for the Texas A&M Institute for Preclinical Studies. She has over 25 years of quality assurance, regulatory compliance, and combined research experience in industry... Read More →
avatar for Arif Demirel

Arif Demirel

Senior Manger, Archives, Charles River Labs
Arif Demirel is the Senior Manager of Archives at Charles River Laboratories and oversees the global archiving operations for Charles River. He has served in various roles, including reporting and GLP auditing. He is the current SASS chair and IACUC chair at Charles River - Horsham... Read More →
avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →


Wednesday April 11, 2018 10:30am - 12:00pm PDT
Platinum 9&10

12:00pm PDT

Networking Lunch with Exhibitors and Posters
South of the Border Buffet Mexican Chopped Salad Chips, Salsa and Guacamole
Pinto Pot Beans Pollo Asada
Skirt Steak Asada Roasted Corn and Tomato Rice
Warm Flour Tortillas
Mango Cheesecake
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk) Iced Tea

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Wednesday April 11, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

12:00pm PDT

12:00pm PDT

Education Committee (EdCom)
The Education Committee will not hold a committee meeting; however, join fellow SQA Education Committee members for lunch.

Wednesday April 11, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

12:00pm PDT

Southern Regional Chapter of SQA (SRCSQA)
The Southern Regional Chapter of SQA (SRCSQA) will have a reserved lunch table on Wednesday.  If you live or work in the Southern Region, please join us.  We look forward to meeting you!  SRCSQA serves as the focal point for Quality Assurance interests in the region of Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Oklahoma, South Carolina, Tennessee and Puerto Rico.

Wednesday April 11, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom

1:30pm PDT

Session U - GLP Track
U-1  Enhancing Data Quality for Studies and Submissions to CVM

​​​​Abstract:
High quality studies and submissions are critical to the review process at the FDA Center for Veterinary Medicine (CVM).  Due to the limited number of studies used to base their regulatory studies on, CVM reviewers not only use final study reports, but also review the accompanying raw data when assessing a study.  Additionally, CVM devleoped a Quality Assurance Study Review (QASR) group to review the data quality of submissions.  By building in quality from the beginning of a study and throughout the entire submission process, Sponsors can reduce the number of questions and issues reviewers may have.  This presentation will focus on how Sponsors can build quality into their GLP and GCP studies and submissions and minimizing  protocol non-concurrence and technical section incomplete letters.

Category:
Animal Health

Level of Content:
Advanced

U-2  Dealing with Emerging CVM Study Director and Protocol Issues

​​​​Abstract:
Protocol review and concurrence by the FDA’s Center of Veterinary Medicine (CVM) allows sponsors to receive CVM reviewer comments about the adequacy of their protocols prior to conducting the study and is viewed as highly beneficial.  However, recent protocol non-concurrence letters have highlighted issues, such as study director masking, issuing protocol amendment, or lack of independence of the QAU, that may be difficult to address or may conflict with regulatory regulations.  This presentation will highlight some issues noted on recent CVM communications about protocols and study director issues and provide suggestions for how to deal with these topics.

Category:
Animal Health

Level of Content:
Advanced

U-3  Benefits and Challenges of Electronic Data Capture Systems in Animal Health Studies

​​​​Abstract:
Electronic data capture systems (EDCS) are useful in capturing data for submission to regulatory authorities. EDCS are commonly used in a variety of industry and regulatory environments: analytical, laboratory, and field; efficacy and safety; human, crop and animal health; EPA, FDA and USDA. Despite the common use of EDCS, there continues to be issues at the sponsor and user level. This presentation will examine these aspects from the animal health in-life data collection aspect primarily, but the concepts span the various environments.

Category:
Animal Health

Level of Content:
Advanced

Moderators
avatar for Fredda Shere-Valenti

Fredda Shere-Valenti

Have Passport Will Travel, Retiree and Volunteer
I'm presently happily retired and loving my volunteer work and traveling. Prior to retiring, I worked for FDA for almost 40 years, including 13 years at the Center for Veterinary Medicine in the Division of Compliance. My joy there was training the field consumer safety officers... Read More →

Speakers
avatar for Damon Bradley

Damon Bradley

Data Manager, Bayer Animal Health
Damon Bradley is the data manager for Bayer Animal Health, North America. He has been involved with one aspect or another of pharmaceutical research for over 20 years including animal technician, bioanalytical chemist, monitor, and quality assurance. He has been the data manager at... Read More →
avatar for Debi Garvin

Debi Garvin

GLP/GCP Manager, Huvepharma, Inc.
I was President of Pacific Rim Consulting and Director of the West Coast Quality Training Institute from 1993-2015. I closed the businesses to take a job with FDA setting up the Quality Assurance Data Review (QASR) group. After 2 1/2 years, I accepted a job with Huvepharma, an International... Read More →
avatar for Deborah Linton

Deborah Linton

Sr. Clinical Research Coordinator, The Veterinary Consultancy, LLC
I have been in veterinary pharmaceuticals, GCP and GLP, for my entire career (30+ years!). I like clinical trials, GLP studies, and training.


Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 5&6

1:30pm PDT

Session V - GMP Track
V-1  Oral Poster: Quality Compliance in Global Drug Supply Chain: Examining the US Regulatory Response

Abstract:
Background: The US FDA enforces regulations of active pharmaceutical ingredients (APIs) manufactured abroad and used in drug products commercially sold in the U.S. However, ensuring API quality is challenging in this era of globalization where approximately 80% of API is sourced from either India or China.  This research examines findings from FDA inspection of API manufacturers located within and outside of U.S. to understand the underlying causes for non-compliance.
Methods: A comprehensive literature review was conducted to better understand the landscape of quality issues associated with APIs manufactured in U.S. and abroad. FDA warning letters from the past 5 years concerning the quality of APIs are examined to detect trends in compliance. In addition, FDA’s inspectional observations (Form FDA 483) will be obtained through FOIA requests and analyzed for content specific to API deficiencies related to quality.
Results: Findings from the literature review demonstrates that there are concerns regarding API quality from foreign manufacturers. However, little research has been conducted to understand why these quality issues exist. Investigation into this issue is challenging because companies typically do not publicly disclose API origin. The results of the ongoing analysis of the FDA warning letters and 483s will be reported. The findings from this research will provide a deeper understanding of the quality issues associated with APIs manufactured abroad, discover reasons for these quality issues, and may help inform regulators in their efforts to help protect public health.

Category:
Good Manufacturing Practices

Level of Content:
Basic

V-2  Developing a GXP Quality Manual

Abstract: TBA

Category: TBA

Level of Content: TBA

Speakers
avatar for JoAnn Boyd

JoAnn Boyd

Quality Manager, Southwest Research Institute
Jo Ann Boyd, BS/MBA, is quality assurance manager for Southwest Research Institute (SwRI) Chemistry & Chemical Engineering Division (C&CED). Ms. Boyd has Lead Auditor training for ISO 9001, ISO/IEC 17025,17020, and NQA-1 requirements with extensive experience establishing quality... Read More →
avatar for Nahae Kim

Nahae Kim

Undergraduate Researcher, University of Southern California
Hannah Kim is an upcoming 3rd year undergraduate at the University of Southen California. Currently, she is researching with the USC International Center for Regulatory Science. After graduating in 2019, she hopes to pursue her PharmD.
avatar for Eunjoo Pacifici

Eunjoo Pacifici

Director, International Center for Regulatory Science: Assistant Professor, University of Southern California
Dr. Pacifici worked at Amgen conducting clinical research focusing her efforts initially on managing U.S. investigational sites and central laboratories. She then moved to the Asia Pacific/ Latin America group interfacing with local clinical and regulatory staff in Japan, People’s... Read More →
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →
avatar for Nancy Smerkanich

Nancy Smerkanich

Assistant Professor Regulatory & Quality Sciences, University of Southern California School of Pharmacy
Dr. Smerkanich has her doctorate and is an Assistant Professor in the Department of Regulatory and Quality Sciences at the University of Southern California. She leads the clinical/regulatory courses while continuing to provide regulatory knowledge support to her academic and industry... Read More →
avatar for Amelia Spinrad

Amelia Spinrad

Regulatory Knowledge Support Administrator, USC International Center For Regulatory Science
Amelia Spinrad, MS is currently a Regulatory Knowledge Support Administrator working at the International Center for Regulatory Science on projects with the Southern California Clinical and Translational Science Institute (SC-CTSI). She manages a regulatory research and her main project... Read More →
KW

Kim Watson

Stone Environmental, Inc
Kim has over 35 years of experience in all phases of production and laboratory procedures, quality control and quality assurance, QA management and project management in an environmental analytical laboratory in the context of EPA regulated environments (GLP, RCRA and CERCLA). She... Read More →


Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 1&2

1:30pm PDT

Session W - I.T. Compliance Track
W-1  Electronic Data Integrity – Take Action Now

Abstract:
Part 11, Annex 11, and similar regulations have been in place for years to ensure electronic data integrity.  However, the FDA, EMA, MHRA, WHO, and PIC/S have all seen the need to publish additional documents in the last few years to address widespread data integrity issues.
By now many IT and Quality Assurance professionals at GMP, GCP, and GLP compliant organizations are familiar with the acronym ALCOA and know that the ALCOA principles are the keys to data integrity.  They might even be participating in Data Integrity compliance assessments, much like the Part 11 compliance assessments of a few decades ago.  But, what actions will be the outcome? And, can these actions start now?
The answer is ‘yes’.  Unlike the Part 11 compliance initiatives of the 1990s, many actions required to address data integrity vulnerabilities can be addressed without expensive computer system replacement programs.
This presentation will describe actions that organizations can take now to prevent or remediate electronic data integrity gaps in the following 10 critical areas:  security and user access, audit trails, back-ups, record storage, record copies, validation, issue investigation, out-sourced services, out-sourced systems, and training.
And, since much can be learned from FDA Warning Letters about what not to do, we will look at examples of sometimes common and sometimes surprising data-integrity compromising practices that have been cited in the last 2 years.

Category:
IT Compliance

Level of Content:
Intermediate

W-2  Do You Really Know What Records You Have? 

Abstract:
One of the primary objectives of a sound records management program is defensible disposition of unstructured electrconic content that has met retention requirements. The challenge often lies with clearly identifying and classifying the content that is, or needs to be, archived. In today's digital world, electronic content is far surpassing physical content which results in storage of records that are duplicative, obsolete, and/or not appropriately classified. This is particularly true following a merger or acquisition when you 'inherit' large volumes of unknown content that must be stored. Now knowing the true nature of the content results in long-term storage of records for far longer than may be required. However, a manual review of large collections of electronic content is not feasible. The goal of this presentation will be to provide a review of an Auto-Classification Proof-of-Concept project that we recently completed.

Category:
Scientific Archiving

Level of Content:
Intermediate

Moderators
avatar for Mohammed Imran

Mohammed Imran

Senior Quality Assurance Auditor, Smithers Avanza Biopharmaceutical Services
Mr. Imran has 20+ years working in regulated study environment and a MLS (ASCP)-licensed professional, starting as a research associate to QA in 1999. Responsible for performing quality assurance functions for the Bioanalytical Services Unit for non-clinical and clinical GLP/regulated... Read More →

Speakers
avatar for Deb Bartel

Deb Bartel

Praxis Life Sciences
Deb Bartel is a Partner at Praxis Life Sciences where she is responsible for the company’s Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.  Since becoming a part of Praxis in 2007, she has provided guidance to clients in the pharmaceutical, biotech... Read More →
avatar for Joseph Whittemore

Joseph Whittemore

Sr Manager, Enterprise Records & Information Management, Pfizer
Joe Whittemore is a Sr. Manager, Enterprise Records & Information Management at Pfizer. In his current role, he manages the archival of inactive, electronic content across the enterprise. He has over 27 years of experience in the pharmaceutical industry. Throughout his career he has... Read More →


Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 3&4

1:30pm PDT

Session X - GCP Track
X-1  EU, Japan, and USA Inspection Readiness and Conduct 

Abstract: TBA

Category: TBA

Level of Content: TBA

X-2 Using Quality Gates and Quality Triggers for Real Time Compliance with ICH E6(R2)

Abstract:
Quality Management is a new concept for clinical research.  The Quality System Regulation (QSR) became effective for manufacturing in 1996 and stressed Quality Management.  So too, in 1996, ICH E6 became effective for clinical without a hint of Quality Management. Post QSR roll-out, clinical could barely spell QMS (Quality Management System) but the sound principles and values associated with a QMS inevitably began to permeate the lexicon of clinical operations.
Lexicon creep continued from the food, drug, biotech and device industries associated with manufacturing methods and software development including FTA, FEMA/FMECA, HACCP, ISO 14971 and others for identifying and controlling risk (aka risk management).  Clinical has also absorbed concepts from these and regulatory areas pertaining to risk identification and risk control.
Risk was only recently contemplated as part of Risk-Based Clinical Monitoring (RBCM).  Now the concept has moved beyond RBCM expanding into a broader meaning and application within the ICH E6 (R2), where the entire trial process is expected to undergo risk analysis and risk mitigation.
The use of Quality Gates and Quality Triggers will be discussed with analysis of specific options throughout the life of a trial.  A Quality Gate is a standard that must be met before moving to the next step in a process.  A Quality Trigger is an event or target parameter that triggers a quality action, either negative or positive.  Both can complement and add to quality metrics throughout a trial.

Category:
Good Clinical Practices

Level of Content:
Advanced

Moderators
avatar for Kerri Robles

Kerri Robles

Director, Quality Laboratory Practices, BMS

Speakers
avatar for Jacqueline Bushong

Jacqueline Bushong

Director, CQA, Atara Biotherapeutics
Jacqueline (Jackie) Bushong RQAP-GCP, is the Director / Head of Clinical Quality Assurance at Atara Biopharmaceuticals in Westlake Village, CA. She has 20+ years of experience in pharmaceutical/biotech industry in the CQA profession. Previous employers include Kythera, Amgen, Chiron... Read More →
RH

Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Dorcie Jasperse

Dorcie Jasperse

Raland Compliance Partners, LLC
Dr. Dorcie Jasperse has over 30 years of experience in clinical trials and medical research. Working in the government, academic, and commercial settings as a data manager, statistician and epidemiologist, project and program manager, GCP auditor, and manager of GMP auditors.In her... Read More →


Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 7&8

1:30pm PDT

Session Y - Roundtables Track
Y-1  Remote or Multisite Vendor Auditing - Perspectives from a Sponsor and a CRO 

Abstract:
Summary – With subcontracting being the new normal and companies looking at overall efficiencies and cost savings, is there a way to oversee your Vendors without traveling all across the world?
Remote and Multi-site vendor auditing may be the solution for you, but when is it most appropriate to undertake these types of audits.  As a Sponsor, how does one go about conducting an effective remote or multi-site audit?  As a Vendor, how does one accommodate these audits?  What are the benefits, challenges and deficiencies with these types of audits.
This presentation will give answers to these questions from both the Sponsor and CRO perspective.

Category:
Beyond Compliance

Level of Content:
Intermediate 

Moderators
avatar for James Farmer

James Farmer

Sr. Manager, Regulatory Compliance, Charles River
James Farmer is the Sr. Manager, Regulatory Compliance at Charles River Laboratories – Nevada, a safety assessment site conducting GLP studies. In this role he is responsible for the Quality Program of the Nevada facility to include overseeing various projects such as Regulatory... Read More →

Speakers
CB

Carla Buckley

Charles River Laboratories Nevada
avatar for Sherry Lee Dawson

Sherry Lee Dawson

Manager, Regulatory Compliance, Charles River Laboratories Montreal ULC
Sherry Lee Dawson, is a Quality Assurance Manager at Charles River Laboratories Montreal ULC, a safety assessment site conducting GLP studies. In this role she oversees various projects, including Regulatory Inspections, Sponsor Audits, Vendor Audit program for her site, quality metrics... Read More →
avatar for Lucy Wingett

Lucy Wingett

Head of GLP Strategy, Genentech, Inc.


Wednesday April 11, 2018 1:30pm - 3:00pm PDT
Platinum 9&10

3:00pm PDT

Networking Beverage and Snack Break with Exhibitors and Posters
Housemade blueberry and raspberry bars
Assorted Soft Drinks (Pepsi Products) Bottled Water
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

To view the list of posters and their abstracts, please visit the Poster Listing on the Annual Meeting website. (Posters will be attended by their authors during the afternoon break on Tuesday, 10 April 2018, 3:00-3:30 PM.)

Wednesday April 11, 2018 3:00pm - 3:30pm PDT
Marquis Ballroom

3:30pm PDT

Session AA - GMP Track
AA-1  Letters from FDA: Warning Letters, 90-Day Letters and the trends behind them

Abstract: TBA

Category: TBA

Level of Content: TBA

AA-2  30-minute interactive audience Q&A

Moderators
MC

Megan Callan

Manager Regulatory Compliance, Charles River Laboratories
Megan Callan is the Manager of Regulatory Compliance at Charles River Laboratories. She is responsible for quality assurance required for GLP and GMP testing conducted at the Cleveland, OH site. She started her career working in microbiology laboratories for pharmaceutical/biotech... Read More →

Speakers
avatar for Sarah Barkow

Sarah Barkow

U.S. Food and Drug Administration
Sarah Barkow is a Team Lead for Manufacturing Quality Guidance and Policy in CDER’s Office of Manufacturing Quality at the FDA. She was co-lead author on the recently released draft guidance for industry, Data Integrity and Compliance With CGMPs. Dr. Barkow holds her Ph.D. in Physical... Read More →


Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 1&2

3:30pm PDT

Session BB - I.T. Compliance Track
BB-1  Virtual Auditing in the Cloud

Abstract:
Virtual Audits are Here!  Now, with advancements in technology, auditors can assess an organization virtually, without having to spend time traveling or incurring travel-related expenses.  However, there are several questions that arise:
1. Are virtual audits safe and effective?
2. When are virtual audits viable?
3. What technology(ies) are available?
4. What is lost or gained with a virtual audit?
5. Do virtual audits comply with regulatory requirements?
6. Will virtual audits replace traditional audits?
7. How long should a virtual audit last?
8. How can companies offer, support, and control virtual audits?
These are just some of the questions that are raised when the topic of "virtual audits" is raised.  This presentation will not only raise these questions to inspire attendees to seriously consider the topic, but answers will be given.  Bold statements may be made to encourgage conversation such as, "is it appropriate for auditors to use body language as an effective tool for assessing auditees?", something that is lost in a virtual audit.  
Regardless if it is embraced or not, virtual audits are real and a rapidly becoming a common practice.  It is important to be well versed in the topic and capable of stating your position, for or against, whatever that may be, with the ability to properly influence decision makers.  This presentation is designed to provide attendees with this ability, regardless of position.

Category:
IT Compliance

Level of Content:
Intermediate

BB-2 Cloud and SaaS in GxP – Getting It Right from the Start


Title:
Cloud and SaaS in GxP – Getting It Right from the Start

Abstract:
Cloud computing models and SaaS (software as a service) applications are increasingly being adopted by regulated companies, such as those producing pharmaceuticals, biological products, and medical devices, as well as organizations conducting clinical trials and GLP studies.  However, this is still new territory when it comes to compliance, inspections, and software validation.
For organizations considering the move to a new computing model, the following areas are crucial to address before making the transition:
Cloud computing model selection:  Implementation of Cloud computing models can provide many benefits, but also introduce some new, significant risks.  Regulations such as 21 CFR 11 and Annex 11 can impact the model you choose and the subsequent actions needed to retain compliance.
Vendor Selection:  Transitioning to a Cloud computing model will result in shifting responsibilities from internal IT and Quality Assurance professionals to the vendor’s staff.  It’s important to ask the right questions during risk-based audits or in supplier qualification questionnaires to ensure regulatory compliance, system reliability, and business stability.
Vendor Agreements:  And finally, a formal agreement, e.g., Service Level Agreement (SLA), is needed.  Contracts containing the right terms, KPIs, and responsibilities can be powerful tools for mitigating the quality, regulatory, and operational risks introduced by out-sourced computing models.

Category:
IT Compliance

Level of Content:
Intermediate

BB-3  21 CFR part 11 - 20 Years Later


Abstract:
In August of 1997 the FDA released 21 CFR part 11 to the industry.  The regulation was met with confusion as to exactly what it meant, who was responsible for the compliance (vendors or end users), and how to make every computer system compliant.  The FDA then released guidance documents, the industry grasped on to legacy systems, and software developers started incorporating part 11 compliance functionality.  And then came the Scope and Guidance in 2003 and there was light at the end of the tunnel.  Fast forward to today; where we have come since the beginning?  How has technology changed?  Do we know what it all means, or are there still questions to ask?  And now with cloud systems, virtual employees, and everything going digital, do we know who is responsible for all those records? Are we any closer to compliance than we were in 1997?
Key Take-Aways:
•          Understand where part 11 has taken the industry
•          Learn how technology has adapted to the regulations
•          Discover different approaches for how companies have complied with the regulation
•          See how you can leverage experience and industry knowledge to be compliant

Category:
IT Compliance

Level of Content:
Intermediate 

Moderators
avatar for Patricia Miller

Patricia Miller

Sr. Mgr, QA IT, Global Quality Systems, Seqirus, Inc.
Ms. Patricia Miller is a Senior Manager of QA IT in the Global Quality Systems Group at Seqirus, Inc. in Holly Springs, NC, where she oversees the compliance and data integrity of regulated computerized systems across the entire company, including the R&D and manufacturing systems... Read More →

Speakers
avatar for Deb Bartel

Deb Bartel

Praxis Life Sciences
Deb Bartel is a Partner at Praxis Life Sciences where she is responsible for the company’s Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.  Since becoming a part of Praxis in 2007, she has provided guidance to clients in the pharmaceutical, biotech... Read More →
avatar for Steven Thompson

Steven Thompson

Sr. Manager, Prof. Svcs., ValGenesis, Inc.
Just mention auditing, validation, CSV, technology, Artificial Intelligence / Machine Learning, cybersecurity, scuba diving, or animals (especially dogs & elephants) and we'll have a great conversation.
avatar for John Zenk

John Zenk

CSols, Inc.
John Zenk is the Validation Services Manager at CSols, Inc., the Premier Laboratory Informatics Consultancy, where he leads a team of consultants specializing in the validation of laboratory informatics systems.  He has been involved with computer software validation in GLP... Read More →


Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 3&4

3:30pm PDT

Session CC - GLP FDA CDRH and J-GCP Track
CC-1  CDRH Update (GLP-oriented)

CC-2 Revision of J-GCP based on ICH-GCP E6 (R2)

Abstract: TBA

Category: TBA

Level of Content: TBA


Moderators
avatar for Fredda Shere-Valenti

Fredda Shere-Valenti

Have Passport Will Travel, Retiree and Volunteer
I'm presently happily retired and loving my volunteer work and traveling. Prior to retiring, I worked for FDA for almost 40 years, including 13 years at the Center for Veterinary Medicine in the Division of Compliance. My joy there was training the field consumer safety officers... Read More →

Speakers
avatar for Annabelle Crusan

Annabelle Crusan

FDA
Annabelle Crusan, DVM, MS is a Veterinary Medical Officer at the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH) at FDA. She reviews proposed and completed animal studies for evaluation of cardiovascular and orthopedic devices. She serves as liaison... Read More →
AJ

Antionette Johnson

Consumer Safety Officer, FDA
Antionette Johnson is a Consumer Safety Officer in the Office of Compliance, Division of Bioresearch Monitoring (BIMO), at FDA’s Center for Devices and Radiological Health (CDRH). She has been managing the Good Laboratory Practice (GLP) compliance program for nonclinical studies... Read More →
avatar for Toshiaki Tamura

Toshiaki Tamura

Astellas Pharma Inc
Toshiaki Tamura, PhDClinical QA Director, AstellasCQA for 17 yearsAstellas from 2005, Fujisawa from 1983PhD on Biochemistry


Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 7&8

3:30pm PDT

Session DD - Roundtables Track
DD-1  Next Generation Quality Management Systems 

Abstract:
With the adoption of the ICH GCP E6 R2 requirements and the latest industry guidance, it is important for sponsor companies and Clinical Research Organizations (CROs) to re-evaluate and implement an enhanced Quality Management System (QMS).  This session will provide information on recent changes to industry requirements, outline the components of a modern QMS, provide examples on how to apply the QMS at all levels of your organization and take a look at some upcoming industry trends. Session participants will be able to take this knowledge back in to their organizations, improve their QMS and better prepare for the future.
Each presentation will include real life examples and discuss collaboration between the Quality organization and key stakeholders. Topics covered in the session include:
-An effective QMS framework that encompasses regulatory requirements, industry guidance, and sponsor requirements
-A focused review of some key QMS elements – Quality Policy, Quality Manual, Risk Management, Business Continuity, Quality Oversight and Controlled Documents
-Overview and examples of how to put a robust QMS in practice at the partnership, program, and project level for effective quality oversight and first time quality performance of clinical trials
-A look to the future – eQMS, wearables, eInformed Consent, Real World Data

Attendees will gain knowledge about current QMS requirements, the QMS in practice and what to plan for in the future.  While requirements vary by country, company and business segment, every organization in the Biopharmaceutical space can benefit from the topics covered in this discussion.

Category:
Beyond Compliance

Level of Content:
Advanced

Speakers
avatar for Janita Hammock

Janita Hammock

Vice President, Project Quality Management, PAREXEL International
Janita Hammock is a Vice President of Project Quality Management at PAREXEL International a leading Clinical Research Organization (CRO). She is a clinical trial and quality professional with over 30 years of industry experience including experience with global clinical trials, strategic... Read More →
avatar for Deborah Wade

Deborah Wade

VP Quality Management System Oversight, PAREXEL International
Over twenty five years of healthcare industry experience including Quality Management Systems, global clinical trials, strategic partnerships, medical device manufacturing and pharmacy. The last 18+ years have been focused on GCP and clinical trial GMP, Quality Assurance and Quality... Read More →


Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 9&10

3:30pm PDT

Session Z - GLP Track
Z-1  How the Poison Squad contributed to the 1906 Pure Food and Drug Act 

Abstract:
Dr. Harvey Wiley’s concern for pure food led him to question the safety of chemical preservatives in the public food supply.  At that time, it was common to preserve meats with saltpeter, ketchup with benzoic acid, and milk with formaldehyde, just to name a few.  Starting in 1902, he formed the Poison Squad, to test the effects of some of the most commonly used food additives on human volunteers.  Young men volunteered for these trials, pledging one year of service to receive three square meals a day of intentionally poisoned food.  The information generated by these ‘human lab rats’ led, in part, to the promulgation of the 1906 law.

Category:
Other

Level of Content:
Basic

Z-2 GLP Test, Control and Reference Substance Preparation and Characterization: The Roles of the Study Director, Test Facility Management and the Quality Assurance Unit


Abstract:
Vincella Erickson, Carol Lee and Margaret Coyle-Rees, Ph.D, RQAP-GLP
Under the Final Rule of the Federal Insecticide, Fungicide and Rodenticide Act, the EPA clearly states that characterization of test, control and reference substances intended to be used in studies meant to support research and marketing permits under 40 CFR Part 160 is necessary to ensure the integrity of studies. Characterization testing is typically conducted at the production or synthesis phase and must therefore be available on or before a study is initiated. Requirements for the production or synthesis are not addressed in the regulation in the same manner as is the characterization; however, the accuracy and retention of such records to support the preparation of test, control and reference substances are critical to support the reconstruction of the study. This presentation provides a framework for good documentation practices on test, control and reference substance preparation, and the importance of such documentation for the US EPA GLP requirement of characterization. Further, the impact of the OECD GLP Draft Advisory Document 19 on the Management, Characterization and Use of Test Items will be discussed, as well as the roles and responsibilities of the Study Director, Test Facility Management and the Quality Assurance Unit.

Category:
Good Laboratory Practices - EPA

Level of Content:
Basic

Z-3  Quality Systems for Small Companies: The Struggle is Real ...  and so is the Cost of Nonquality


Abstract:
I can't take it anymore. Well, I can but I don't want to. I'm seeing a disturbing trend in my travels around the country as a quality assurance (QA)/systems consultant. It has to do with small pharma and biotech companies as well as small vendor companies that provide services to them.  It also involves QA professionals. I'm seeing small companies that: 1) have no true QA presence 2) are giving QA responsibilities to staff members who have little to no QA experience, and/or 3) have QA staff who don't have the right type of QA experience. There are several reasons for this trend including but not limited to: 1) Small companies don't often have the budget to hire a QA Director with big pharma experience or over ten years of experience that counts and 2) They love to promote from within. This presentation will explore this trend and provide specific tips and strategies small companies can use to build the robust quality system needed to successfully operate in the pharmaceutical and biotech industry.  Your product may be stellar! Your company's technical expertise may be outstanding! You may deliver fantastic clinical results! However, if your quality system is weak; if it causes issues for a sponsor company; if it introduces gaps and concerns for regulators; if clinical trials can't be reconstructed; if data quality is questionable; if patient safety suffers .... the ultimate kick in the gut will happen in your financials. That's called the cost of nonquality ... and it's real.

Category:
Other

Level of Content:
Intermediate

Moderators
EH

Eva Haszcz

Gloabal Quality Programs Manager, FMC Corporation, Agricultural Solutions
Ms Haszcz has 17 years of experience working in GLP and GMP regulated environments. Since 2009 she is the Global Quality Programs Manager within the Regulatory Department at FMC Corporation. Through her work in a global regulatory setting she has gained an extensive understanding... Read More →

Speakers
avatar for Vincella Erickson

Vincella Erickson

Valent USA Corporation
Ms. Erickson facilitates all Valent Technical Center GLP Standards and QA activities including in-life, raw data and final report audits; assists in the establishing of policies and procedures to ensure compliance with domestic and international GLP standards for Valent QA operations... Read More →
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →
avatar for Penelope Przekop

Penelope Przekop

CEO/Principal Consultant, PDC Quality Consulting
Penelope Przekop is an outcome-driven Senior Executive and Thought Leader with more than 25 years of success across the biotech, pharmaceutical, healthcare, teaching hospital, clinical trials, manufacturing, and design industries. Her broad areas of expertise include quality assurance... Read More →


Wednesday April 11, 2018 3:30pm - 5:00pm PDT
Platinum 5&6

5:00pm PDT

5:00pm PDT

Beyond Compliance Specialty Section (BCSS)
The Beyond Compliance Specialty Section (BCSS) serves the Society of Quality Assurance (SQA) by providing an extension of quality assurance beyond regulatory requirement compliance.  All are welcome.  Come join us!

Wednesday April 11, 2018 5:00pm - 6:30pm PDT
Desert Springs, Lower Level

5:00pm PDT

Clinical Specialty Section (CSS)
Please join the Clinical Specialty Section for our annual face-to-face meeting.  Members are encouraged to attend and people interested in our group are welcome to attend and learn about the activities in CSS.

Wednesday April 11, 2018 5:00pm - 6:30pm PDT
La Jolla/Los Angeles, Lower Level

5:00pm PDT

Good Laboratory Practice Specialty Section (GLPSS) with FDA/EPA Regulators
The Good Laboratory Practice Specialty Section (GLPSS) meeting is an opportunity for SQA members to directly interact on a variety of timely FDA & EPA GLP-related subjects involving current industry topics.  The meeting provides attendees a lively discussion on “hot” topics and experiences. Agency representatives are invited and may provide opportunities for direct discussion on current trends and issues. Come prepared for a lively event and early to get a prime seat

Wednesday April 11, 2018 5:00pm - 6:30pm PDT
Platinum 1&2

5:00pm PDT

University Specialty Section (USS)
The University Specialty Section (USS) welcomes all who are university-based, collaborate or work with academia or are interested in learning more about quality processes adapted to universities systems. Members of the USS represent a highly diverse group of US and International QA professionals experienced in the application of quality system approaches supporting basic biomedical research to translational medicine including environmental safety in both regulated (GxP) and non-regulated (GRP) environments. This is the opportunity to network, put some names to the faces, get to know one another and share your experiences. Please join us!

Wednesday April 11, 2018 5:00pm - 6:30pm PDT
Newport Beach/Rancho Las Palmas, Lower Level

7:00pm PDT

A Night at the House of Blues - Separate Registration Required
Wednesday April 11, 2018 7:00pm - 10:00pm PDT
The House of Blues 400 Disney Way #337, Anaheim, CA 92802
 
Thursday, April 12
 

7:30am PDT

Continental Breakfast
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Hotel Breakfast Breads Served with Preserves, Butter
Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Breakfast Sandwich, Eggs and Cheese
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Thursday April 12, 2018 7:30am - 8:30am PDT
Marquis Ballroom North

7:30am PDT

7:30am PDT

Registration Desk Open
Thursday April 12, 2018 7:30am - 5:00pm PDT
Platinum Registration

8:30am PDT

Session EE - GLP Track
EE-1  The State of QA (GLP SS) 

Abstract: The ‘State of QA’ session is based on anonymous comments compiled into a SWOT, which will be used to collect feedback from each session attendee, following which an article will be published in Quality Matters, and the voice of the membership will be brought to the Board of Directors for assessment and action.

Category: GLP

Level of Content: Intermediate

Speakers
avatar for Greg Furrow

Greg Furrow

Vice President, Quality and Compliance, Southern Research
Greg Furrow is vice president of Quality and Compliance at Southern Research Institute where he is responsible for Quality Assurance, EH&S, Biosafety, Export Control, Government Security, Information Technology, Human Resources and quality improvement processes. He has been at Southern... Read More →
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →


Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 5&6

8:30am PDT

Session FF - Bioanalytical Track
FF-1   EMA Bioequivalence Inspections in the US - What to Expect and How They Differ from US FDA Bioequivalence Inspections

Abstract:
As an international contract research organization studies conducted by Covance are submitted to various regulatory authorities.  The resulting inspections differ significantly and come with different challenges.  During this session details related to the planning, conduct and follow up from one EMA/FDA inspection will be reviewed and discussed.

Category:
Bioanalytical

Level of Content:
Intermediate

FF-2  Bioanalytical Audit Due Diligence and Risk Management


Abstract:
In this session we will discuss how CROs prepare to host and respond to audits: Pre-Qualification, Re-Qualification, and Data (BA/BE & Pivotal Studies) - by identifying the risks sponsors are looking to mitigate, and how Bioanalytical CROs address real and perceived risks.

We will hear from Sponsors, Auditors, and CROs, and their real life experiences.

Category:
Bioanalytical

Level of Content:
Intermediate


FF-3  Investigation of incurred sample reanalysis failure 


Abstract:
5-fluorouracil (5-FU) is a chemotherapy agent for treating breast and colon cancers.  Capecitabine is also a chemotherapy agent for treating those cancers and it is a prodrug which is enzymatically converted to the active drug 5-FU within the tumor.  Incurred sample reanalysis (ISR) of 5-FU were performed for patients dosed with either 5-FU or capecitabine in one clinical trial. ISR analysis on samples from patients that were dosed with 5-FU met acceptance criteria. However, ISR analysis on samples from patients that were dosed with capecitabine in the same study was failed. It was suspected that capecitabine and its upstream metabolites 5’-DFCR or 5’-DFUR, alone or in combination, may convert to 5-FU following sample collection. An investigation was performed. Blank plasma was spiked individually with capecitabine, 5’-DFCR and 5’-DFUR at potential Cmaxconcentrations and were left at testing conditions before analysis for 5-FU. It was confirmed that 5’-DFUR was continuing to convert to 5-FU even after samples had been frozen. To prevent the conversion, a further investigation was performed using different conditions with various inhibitors such as 5-nitrouracil, 7-deazaxanthine or tetrahydrouridine with formic acid, acetic acid, and citric acid. This investigation led to the development of a specialized sample collection procedure. A bioanalytical method was then developed and validated for the determination of 5-FU in human plasma from patients dosed with capecitabine utilizing the above sample collection procedure. This new approach has resulted in acceptable ISR results for 5-FU from patients dosed with capecitabine.

Category:
Bioanalytical

Level of Content:
Advanced 

Moderators
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →

Speakers
avatar for Xiao Ding

Xiao Ding

Genentech
Xiao Ding received her PhD degree in Analytical Chemistry in 1997 from University of Arizona and completed her postdoctoral training in University of Arizona in 1999. Since 1999, she has worked in pharmaceutical industry including Boehringer Ingelheim, Amgen and Genentech. She has... Read More →
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
TR

Timothy R. Olin

Ionis Pharmaceuticals
avatar for Timothy Valley

Timothy Valley

Covance
Timothy Valley is an Associate Director Quality Assurance – Regulatory Policy and is responsible for overseeing client and regulatory inspections.  He joined Covance Laboratories in 1992 working 5 years as a bench level chemist followed by various positions in the Quality Assurance... Read More →
avatar for Kim Wheeler

Kim Wheeler

QA Manager, PPD
Ms. Wheeler started in GLPs in December of 1980 at A.H. Robins Research. She has over 10 years’ experience in analytical method development in GLPs /GMPs, having worked for Robins Research Division and Sergeant’s Pet Products.Kim Wheeler is a MLT-AD, ASCP, and managed a hospital... Read More →


Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 1&2

8:30am PDT

Session GG - Beyond Compliance/Other
GG-1  Metrics that Matter: Quality Service Indicators

Abstract:
What is easy to measure does not always yield meaningful results.  For example, when interviewing a Quality Assurance professional, you can query the number of audits completed.  Should the quantity be high one may infer the candidate is highly experienced. Through follow-up questions, it may become clear that the individual worked only as a co-auditor on a single program.
This session shall discuss how to develop effective measures, review commonly collected metrics and suggest alternative quality indicators.  Attendees will learn about data collection methods such as surveys, a little about statistics (the "n") and suggested methods for communicating results to management.  These tools can be used across the GxPs across Stakeholders although examples will be from a business perspective.

Category:
Beyond Compliance

Level of Content:
Advanced

GG-2  Beyond Just Compliance:  Using the Innovation and Creativity Processes in Addition to CAPA


Abstract:
CAPA is effectively your compliance and deviation management system. The CAPA process provides analytical techniques and methods that have been proven to fix and prevent problems but what about innovation? What about creativity and forward thinking? How can we go beyond Lean and Six Sigma to reach a true state of creativity and innovation?
Did you know that there are processes that can be followed closely to achieve innovation and creativity just as much as there are processes to keep companies in compliance?
Learn how to move above and beyond CAPA management and into creative and dynamic innovation. The author will instruct you in the latest risk-management thinking to exploit and facilitate innovative ideas and easily gain support from executives and from within even rigid company cultures.

As you would expect, this type of innovation and creativity along with compliance will completely change the dynamic of quality and R&D for the better!

Consider the following takeaways from this session:
-New inventive ideas that reap practical economic results
-Learn how to solve a problem without investigation and root-cause analysis
-Learn how to apply a risk-based system to exploit and facilitate innovative idea
-Learn how to distinguish between when to use the CAPA analytical technique and when to use innovative and creative techniques for improvement
-Learn how to incorporate R&D principles with quality principles

Category:
Beyond Compliance

Level of Content:
Intermediate

GG-3  Learnings from a Recently Implemented Metrics and Continuous Improvement Program


Abstract:
Within Biometrics at Biogen, we have a Quality Business Performance Team that monitors and reports monthly both performance and quality metrics.  Currently we are collecting 100 measures across Data Management, Statistical Programming and Biostatistics. The reporting of key metrics (for example, changes to final outputs and frequency of database unlocks) along with associated tolerance thresholds are discussed at a Business Operations Forum consisting of cross-functional Management and key Quality and Operational Leads. Actions and next steps are determined within a continuous improvement framework consisting of investigation of the issue, cross functional discussion, identification of root cause and preventive actions.
Our presentation will share initiatives that have been implemented to improve quality and performance within Biometrics such as the quality of final Tables, Listings and Figures, database lock and eCRF development.  In addition, we will share the evolution of our metrics and continuous improvement strategies that began as a manual process over a year ago.  At Biogen, the operational model for clinical trial execution is complex and ever changing.  We are focusing our efforts on partnering across our many vendors, as well as standardization and automation of collection and reporting of metrics.
Our metrics and continuous improvement strategy has brought transparency and awareness of quality to all members of the Biometrics team.  The result of this initiative has increased vigilance around performance and efficiency and is impacting how we approach quality in our organization.

Category:
Beyond Compliance

Level of Content:
Intermediate


Moderators
avatar for Kerri Robles

Kerri Robles

Director, Quality Laboratory Practices, BMS

Speakers
avatar for Kim Jackson

Kim Jackson

Senior Technical Field Services Process Architect, MasterControl, Inc
Kim Jackson has more than 10 years of experience in healthcare technology, information science, and project management. As a field services process architect, she works with FDA- and ISO-regulated companies to develop automated quality event management processes for use with best-in-breed... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Mrs. (Holbrook) Thompson has been working in quality assurance for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelors of Science at North Carolina State University. Mrs. Thompson has been a Registered Quality Assurance Professional... Read More →


Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 3&4

8:30am PDT

Session HH - Medical Device Track
HH-1   EU-MDR QMS Strategy

Abstract:
In the past year, many changes to quality management system (QMS) establishment, maintenance and documentation have impacted the medical device and diagnostic industry. The European Union Medical Device Regulation (EU-MDR) mandates that the QMS should set high standards and support quality beyond satisfying compliance requirements for performance safety and outcomes. As well as establish a risk-based approach to the overall QMS process. This will add to planning and training on changes across the entire quality system with the addition of new SOPs, manuals and reporting functions. Aligning QMS with the new regulatory requirements require increased resources to maintain its management.
  • Review of EU MDR specifics for QMS strategy revision
  • Practical implementation tips

Category:
Medical Device

Level of Content:
Advanced

HH-2  US FDA 21 CFR Part 58 Good Laboratory Practice, Proposed Rule and Its Impact to Japanese Medical Device Industries

Abstract:
Nonclinical study in compliance with Good Laboratory Practice (GLP) should be conducted to confirm safety prior to perform any clinical investigation of pharmaceuticals, medical device, or HCT/Ps. In the US, 21 CFR Part 58 GLP is regulated to conduct the nonclinical study as well as Ministerial Ordinance of GLPs in Japan. Furthermore, Organization for Economic Co-operation and Development (OECD) principles of GLP have been created in the context of harmonizing testing procedures for the Mutual Acceptance of Data (MAD). Under current regulatory landscape, the United States Food and Drug Administration (US FDA) was issued the proposed rule (Federal Register, Vol. 81, No. 164, August 24, 2016). The purposes of this study are to confirm the background and content of proposed rule, and to consider the regulatory influence of GLPs in Japan.
As background, the proposed rule of US FDA GLP needs to introduce the Animal Rule for pharmaceutical and biological products, to establish the GLP quality system in compliance with ISO 9001, and to newly develop the clause of Animal Welfare policy. Gap analysis on both GLPs between Japan and the US revealed that none of description on veterinary care and attending veterinarian exist in Japan. If site inspection of Bioresearch Monitoring Program conducts in Japan, some nonclinical facility may be issued on the GLP deviation due to lack of description on animal welfare. As of this moment, only GLP facilities which received the AAALAC International accreditation are available to apply the revised 21 CFR Part 58 in Japan.

Category:
Medical Device

Level of Content:
Intermediate

HH-3  Challenges with Interpreting the GLPs for Medical Device Studies

Abstract:
The Code of Federal Regulations 21 CFR Part 58 provides Good Laboratory Practice regulations for non-clinical laboratory studies. These regulations were originally created to provide guidelines for conducting non-clinical studies for pharmaceutical products; however, they now cover a broader scope which includes food additives, biological products, and medical devices. In the realm of medical devices, there is a lack of clarity on how to best apply these regulations, especially for biocompatibility studies. Due to the current broad scope of products for which the GLP’s may be applied, medical device professionals are left to interpret the language of these regulations, using their best judgment to determine how to sufficiently address each requirement. Some common challenges include determining when to conduct a medical device study as GLP, and also determining what test article characterization data is required when conducting a GLP study.

Category:
Good Laboratory Practices - FDA

Level of Content:
Advanced


Moderators
avatar for Bethany Davis

Bethany Davis

Clinlogix
Bethany has over twelve (12) years of experience in the pharmaceutical and research industry. Before joining Clinlogix, Bethany’s experience includes McNeil Consumer Healthcare, Dr. Reddy’s Laboratories and The Commonwealth Medical College.  Bethany has designed and implemented... Read More →

Speakers
avatar for Autumn Lang

Autumn Lang

Clinlogix
Autumn partners with emerging medical device teams by aligning all their various expertise to have the same commercial objectives and goals. With her 18 years of operational and consulting experience in the medical device industry and clinical research, she has successfully led many... Read More →
avatar for Tiffany Sam

Tiffany Sam

Edwards Lifesciences
Tiffany Sam is a biologist and study director for biocompatibility studies at Edwards Lifesciences, the global leader in patient-focused medical innovations for structural heart disease. She draws upon her 9 years of experience working for a rapidly growing medical device company... Read More →
MY

Masayuki Yamato

Tokyo Women's Medical University
avatar for Kazuo Yano

Kazuo Yano

Part Time Assistant Professor, Tokyo Women\'s Medical University
Kazuo Yano received his DVM from the Graduate School of Veterinary Medicine, Hokkaido University, and PhD from the Cooperative Graduate School of Tokyo Women's Medical University and Waseda University. He is a Part Time Assistant Professors at both Universities. He has published 20... Read More →


Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 7&8

8:30am PDT

Session II - Special Topics Track
II-1 - Improving quality to reduce risk through the use of automation

Abstract: 
Automated tools can vastly improve the quality of data in clinical trials and registries, thereby increasing the evaluable data, ensuring valid results, and reducing labor. This session will discuss how to leverage advanced automation when using electronic data capture to ensure quality in the data for the project as a whole in the context of 21CRF11 "contemporaneous."
Modern systems can address site, user, and project level data in addition to subject data in an integrated way. These systems enable eSource by use of well-designed forms and navigation.
Systems that enable integrated feedback facilitate appropriate planning of comprehensive edit checks, logic and automated calculations. Automation can go beyond normal edit checks to include an integrated approach to randomization, inventory,  invoicing, laboratory interfaces, AE/ConMed coding, etc. By automatically generating information from other entries and configuration settings, errors can decline precipitously and monitors can focus on clinical issues.
Additional tools can automatically generate deviations, provide a smart look-up from dictionaries, build drop-down options from other entries, show trends to identify outliers, and take advantage of technologies such as bar code readers, RFID wands, specialized apps, etc. It is important to identify the variables and parameters that will be used to track risk and actions associated with each. Identifying these from the beginning allows automation and effective tracking within the system which result in improved quality. By planning for and automating these daily tasks, study management personnel’s time may be freed up to focus on continuous quality improvement initiatives. Learn how in this session.

Category:
Biotechnology

Level of Content: 
Intermediate


II-2 - Evaluating and validating hosted electronic signature solutions  


Abstract: OECD 17 and 21 CFR Part 11 (including FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application) require that electronic signature solutions meet a host of requirements to ensure that the electronic signature is the equivalent of handwritten signatures. OECD 17 and 21 CFR Part 11 also require these electronic signature solutions be validated. More than fifty electronic signature solutions exist, but not all hosted solutions meet those regulatory requirements. It is the responsibility of users to validate, integrate, and determine if the hosted solution meets regulatory requirements.
The goal of this presentation is to review the following:
  1. Brief overview of the applicable regulations
  2. Points to consider when choosing a hosted signing solution
  3. Integration of a stand-alone hosted electronic signing solution into existing workflows
  4. Lessons learned during validation of a hosted electronic signature vendor
An introduction will provide a brief overview of the OECD 17 and 21 CFR Part 11 documents as they relate to electronic signatures. It will be assumed that attendees are familiar with the current industry best practices for computer system validation.

Category: Other

Level of Content: Intermediate


II-3 – SEND Update (pre-recorded video from Marc Ellison)

Category: SEND

Level of Content: Intermediate

Moderators
LS

Lelia Scott

Senior Director, Global Quality Systems, Charles River

Speakers
ME

Marc Ellison

Product Manager, Instem
avatar for Alicia Browner, PhD

Alicia Browner, PhD

Electronic Data Capture and Trial Management, Prelude Dynamics
Our offerings include both do-it-yourself and premium service (for highly complex studies) on a single validated platform. Come talk to us at booth 205!
avatar for Jennifer Siegrist-Skapura

Jennifer Siegrist-Skapura

Global Computer Validation Quality Assurance Specialist, Charles River Laboratories
Ms.Skapura obtained a BS in biology, followed by an MBA from Wright State University. She has been with Charles River for 14 years and is currently a specialist in the global quality assurance computer system validation group. Her responsibilities include providing QA compliance support... Read More →


Thursday April 12, 2018 8:30am - 10:00am PDT
Platinum 9&10

10:00am PDT

Networking Beverage Break
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

Thursday April 12, 2018 10:00am - 10:30am PDT
Marquis Ballroom North

10:30am PDT

Closing Plenary
Regulatory and Industry Leaders Panel Q & A 

Moderators
avatar for Greg Furrow

Greg Furrow

Vice President, Quality and Compliance, Southern Research
Greg Furrow is vice president of Quality and Compliance at Southern Research Institute where he is responsible for Quality Assurance, EH&S, Biosafety, Export Control, Government Security, Information Technology, Human Resources and quality improvement processes. He has been at Southern... Read More →

Speakers
avatar for Tammy Barkalow

Tammy Barkalow

Assistant Director, Quality Assurance, The IR-4 Project
Tammy White Barkalow, RQAP-GLP is the Assistant Director of Quality Assurance at the Headquarters of the IR-4 Project, a USDA funded, cooperative research project. She is the 2018 President of the Society of Quality Assurance and has 28 years of experience in the QA/GLP arena. She... Read More →
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Kimberly Frazier

Kimberly Frazier

Consultant, Kim Frazier Consulting, LLC
Kimberly Frazier is the Principal Consultant of Kim Frazier Consulting, LLC located in Mattawan, MI providing consulting services in GLP Quality Assurance and Animal Welfare Compliance. For the last twenty-five years, she has worked in various aspects of the regulatory environment... Read More →
avatar for Dr. Krishna Ghosh

Dr. Krishna Ghosh

FDA
Krishna Ghosh, Ph.D. is a Medicinal Chemist with over 20 years of industry experience in Product Development, Manufacturing /Operation/ Business Management, Quality Assurance, Quality Control and Regulatory Affairs in biotech and pharmaceutical companies. She has extensive experience... Read More →
LP

Linda Palagi Lynn

Consultant, LPL Quality Services
avatar for Lisa Sottolano

Lisa Sottolano

Charles River
Lisa Sottolano is the Director of Regulatory Compliance at Charles River, Massachusetts in Shrewsbury. As Director of Regulatory Compliance, Ms. Sottolano is responsible for QA operations at the site. Ms. Sottolano received a BA in Biological Sciences from Rutgers University and a... Read More →


Thursday April 12, 2018 10:30am - 12:00pm PDT
Platinum 5&6

12:00pm PDT

12:00pm PDT

Quality College Networking Lunch
Mediterranean Buffet
Roasted Garlic Red Pepper Hummus and Pita Chips
Spinach, Romaine, Chickpea, Sweet Onion Salad with a Greek Yogurt Dressing Roasted Chicken with Kalamata and Artichokes
Roasted Tomato and Lemon Juice
Seared Salmon and Spinach with Warm Mediterranean Vinaigrette Seasonal Vegetable Risotto
Fresh Fruit Tart and Key Lime Tart
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk)
 Iced Tea

Thursday April 12, 2018 12:00pm - 1:30pm PDT
Marquis Ballroom North

1:30pm PDT

Post Conference Debriefing
Board of Directors members, Program Committee members, and Committee and Specialty Section Chairs are invited.

Thursday April 12, 2018 1:30pm - 3:00pm PDT
Newport Beach/Rancho Las Palmas, Lower Level

1:30pm PDT

Workshop 13 - GLP 202: Regulatory Surveillance Inspections (1/2 day)
RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course provides an overview of the FDA surveillance inspection process, in particular as it applies to GLP facilities. This course describes how to prepare for an agency inspection, how to host the inspection, and how to interact with regulators during and after the inspection. Additionally, this course will touch on the Canadian accreditation/ re-accreditation inspection process.

Objectives
At the end of the course, the participants shall be able to: 
  • Prepare for an agency inspection
  • Host an agency inspection
  • Understand FDA's current thinking and approach during inspections
  • Understand Canada's accreditation/re-accreditation process

Target Audience
This course is targeted to personnel (e.g. management, auditors, study personnel) who participate in regulatory agency inspection readiness activities and/or hosting regulatory inspections.

Agenda
  • Inspection readiness
  • Hosting regulatory inspections
  • Investigator's approach during inspections
  • FDA regulatory expectations and current thinking
  • Canada re-accreditation inspections


Speakers
avatar for Jennifer Bravo

Jennifer Bravo

Senior QA Manager, Charles River Laboratories
Jennifer Bravo is Senior QA Manager at Charles River Laboratories Worcester, MA. The Worcester site provides GLP Bioanalytical and Immunoanalytical services. In her current role, Jen oversees various aspects of the site’s quality systems, including internal audit program, vendor... Read More →
DC

Dominique Chan

Manager of Regulatory Compliance, Charles River Laboratories
Ms Dominique P. Chan is Manager of Regulatory Compliance who currently oversees the Lab Science team of QA auditors. She currently manages a team of 13 auditors, whose main focus is on the various lab datasets, including clinical work. Other key responsibilities include monitoring... Read More →
avatar for Sherry Lee Dawson

Sherry Lee Dawson

Manager, Regulatory Compliance, Charles River Laboratories Montreal ULC
Sherry Lee Dawson, is a Quality Assurance Manager at Charles River Laboratories Montreal ULC, a safety assessment site conducting GLP studies. In this role she oversees various projects, including Regulatory Inspections, Sponsor Audits, Vendor Audit program for her site, quality metrics... Read More →
avatar for James Farmer

James Farmer

Sr. Manager, Regulatory Compliance, Charles River
James Farmer is the Sr. Manager, Regulatory Compliance at Charles River Laboratories – Nevada, a safety assessment site conducting GLP studies. In this role he is responsible for the Quality Program of the Nevada facility to include overseeing various projects such as Regulatory... Read More →
NS

Nina Sahay

Senior Quality Assurance Specialist, Charles River Laboratories
Nina Sahay B.S., RQAP-GLP is the Senior Quality Assurance Specialist at the Skokie facility of Charles River Laboratories. Her primary responsibilities are to assure compliance with the Good Laboratory Practice Regulations and laboratory Standard Operating Procedures at CR. Her 14... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm PDT
Platinum 1&2

1:30pm PDT

Workshop 14 - General 103: The Biologics Super Highway (1/2 day)
RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
Provide an overview of the science behind Ligand Binding Assays used in regulated bioanalysis. The course will cover both PK and ADA assays, and describe some of the areas where auditors should focus their review.

Objectives
At the end of the course, the participants shall be able to: 
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers

Target Audience
Auditors new to bioanalysis and new to auditing large molecules.

Agenda
  • Overview of the science of ligand binding assays (LBAs)
  • PK LBAs
  • ADA LBAs
  • Bioequivalence vs. Biosimilars
  • Biomarkers


Speakers
avatar for Deborah Parker

Deborah Parker

QA Manager, ICON Bioanalytical Laboratories
Deborah Parker is a QA Manager at ICON PLC. She has over three decades of experience in the pharmaceutical industry, with training as a bioanalytical scientist. Having performed analysis using RIAs, Enzyme Inhibition testing, ELISAs, HPLC and LC-MS/MS, her background provided a perfect... Read More →
avatar for Lucy Podbielski

Lucy Podbielski

Associate Director, Toxicology Lab Sciences QA, Charles River Laboratories
Lucy Podbielski is Associate Director, Toxicology Lab Sciences QA, Charles River. She has over 20 years of experience in bioanalytical labs, starting as an analyst and transitioning to QA in 2009. She manages the Toxicology Laboratory Science Good Laboratory Practice Quality Assurance... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm PDT
Platinum 3&4

1:30pm PDT

Workshop 15 - General 101: QA Consulting (1/2 day)
RQAP re-registration units: 1 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
A consultant is an individual who possesses special knowledge or skills and provides that expertise to a client for a fee. This interactive course will give examples of expectations of the sponsor (your client) and also CROs that host audits in certain situations. It will also cover ways of organizing the consulting business with regard to legal organization, tax information, physical office choices, marketing, payment structure, insurance, and other necessities and niceties. This course is targeted for those QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.

Objectives
At the end of the course, the participants shall be able to: 
  • Develop ideas for setting up and running a consulting practice.
  • Weigh the pros and cons of different types of legal and tax options.
  • Learn sponsor's (your client) expectations, needs and methods of interactions.
  • Understand what laboratories/CROs expect from you.

Target Audience
This course is targeted for those QA professionals who want to learn more about consulting or have desire to pursue consulting as a career.

Agenda
  • Introduction
  • Meeting expectations of your client (the Sponsor)
  • What the CROs expect from you as a consultant
  • Setting up and running your consulting company


Speakers
avatar for Angela Eichelberger

Angela Eichelberger

Compliance Specialist III, Charles River Laboratories
avatar for Lisa Fink

Lisa Fink

Senior Quality Technical Consultant, Baxter Healthcare Corporation
Lisa is a Manager II, Quality, Baxter Healthcare Corporation. She has a Bachelor of Science Degree in Chemistry from Illinois State University, an MBA in Management from Roosevelt University, and a Certificate in Total Quality Management for Service Organizations from DePaul University.Lisa... Read More →
avatar for Robin Guy

Robin Guy

GLP and Toxicology Consultant, Robin Guy Consulting, LLC
ROBIN C. GUY, M.S., D.A.B.T., RQAP-GLPRobin has been a toxicology and GLP consultant for the last 18 years for Robin Guy Consulting, LLC. Robin has extensive QA work experience involving administering GLP training courses (FDA, EPA, OECD), assisting labs with recommendations on how... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm PDT
Platinum 7&8

1:30pm PDT

Workshop 16 - General 104: Three Cs of SOPs: Clear, Concise, and Compliant in a Regulatory Setting (1/2 day)
RQAP re-registration units: 1 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This course will cover the full life-cycle of controlled process documents - from creation through archival. Topics will also include responsibilities, training, and non-compliance. Attendees should be prepared to bring examples of questions relating to SOPs (controlled process documents) and SOP management.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP

Target Audience
Anyone who is responsible for life cycle and compliance of these key components of the Quality Management System. This course is applicable to all; GMP, GCP, GLP, and GVP. This course is applicable for beginners as well as experienced personnel.

Agenda
  • Understand the purpose and benefit of effective SOPs
  • Understand the critical role of SOPs in Quality Documentation systems
  • How to write a concise, unambiguous SOP for its intended purpose
  • Define clear responsibilities to promote action and closure within the document
  • Training requirements
  • Manage revisions, nonconformance and deviations from a current SOP
  • Difference between GCP/GLP/GMP
Class will include team exercises

Speakers
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →
avatar for Michelle Thompson

Michelle Thompson

Vice President, FDA Quality and Regulatory Consultants, LLC (FDAQRC)
Mrs. (Holbrook) Thompson has been working in quality assurance for over 15 years and joined FDA Quality and Regulatory Consulting (FDAQRC) in 2015. She completed her Bachelors of Science at North Carolina State University. Mrs. Thompson has been a Registered Quality Assurance Professional... Read More →
avatar for Judy Zahora

Judy Zahora

Head, Project Management Office, Biogen
Ms. Zahora is Global Lead, Process Documentation Management for R&D at Biogen where she defines and implements R&D GxP documentation standards to ensure compliant, clear, and effective documentation of GxP processes. She has over 30 years’ experience working in IT, Finance, Process... Read More →


Thursday April 12, 2018 1:30pm - 5:30pm PDT
Platinum 9&10

3:30pm PDT

Quality College Beverage and Snack Break
Make your Own Trail Mix Bar Assorted Soft Drinks (Pepsi Products) Bottled Water
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Thursday April 12, 2018 3:30pm - 3:45pm PDT
Platinum Foyer
 
Friday, April 13
 

7:00am PDT

Quality College Continental Breakfast
Fresh Orange Juice, Cranberry Juice and Grapefruit Juice Market Style Seasonal Fruit, Melons and Fresh Berries Freshly Baked Anaheim Hotel Breakfast Breads
Served with Preserves, Butter and Regular Cream Cheese Greek and Fruit Yogurts with House-Made Almond Granola Served with Whole, 2% and Fat Free Milk
Scrambled Eggs
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Friday April 13, 2018 7:00am - 8:00am PDT
Platinum 5

7:00am PDT

Registration Desk Open
Friday April 13, 2018 7:00am - 5:00pm PDT
Platinum Registration

8:00am PDT

Workshop 22 - GLP 102: History Behind the FDA GLPs (1/2 day)
RQAP re-registration units: 1 GLP, non-GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This training teaches the history behind the GLPs, why they were written as they were, and how to apply them in today's environment. The fraud uncovered by the FDA was astounding, and led to the creation of the GLPs. Have you heard of the magic pencil study or the swamp? Did you know that tissue masses were removed from live animals to 'take a look to see what was inside'? This presents GLP training in a novel way, by linking fraud to regulations to SOPs to the FDA Compliance Program Guidance Manual to recent 483s.

Objectives
At the end of the course, the participants shall be able to: 
  • Learn the history behind the FDA GLP regulations
  • Learn the correlation between the initial fraud, regulations, and CPGM
  • Learn how to apply the GLPs to situations at their local labs
  • Understand how to apply history learnings to write better findings

Target Audience
Anyone interested in understanding why the FDA GLP regulations were written and how they can be applied, spans from beginner to experienced professionals.

Agenda
  • History prior to 1970s
  • Searle Pharmaceutical, Searle Task Force
  • Industrial Bio-Test Lab
  • Monsanto
  • Hazleton Lab
  • Congressional hearing, Bressler Report
  • Regulatory action, IBT Trial
  • Practical exercises to write robust audit findings by applying history learnings to specific situations


Speakers
avatar for Barbara Munch

Barbara Munch

GlaxoSmithKline
Barb Munch, BS, is Director, R&D Pharma GLP Risk Coordinator in global toxicology, within GlaxoSmithKline (PA, UK). This group conducts GLP in-vivo and in-vitro toxicology studies for pharmaceutical test articles. Her 39-year career has been in the nonclinical regulatory environment... Read More →
avatar for Kathryn Newland

Kathryn Newland

DSRD Global Compliance & Records Management Lead, Pfizer
Kathryn Newland is the Global Compliance & Records Management Lead with Regulatory Strategy and Compliance in Drug Safety Research & Development at Pfizer, Inc. Her responsibilities include leadership and management of the combined Compliance & Records Management organization, setting... Read More →


Friday April 13, 2018 8:00am - 12:00pm PDT
Platinum 10

8:00am PDT

Workshop 23 - CSV 204: SEND-Implementation and Validation (1/2 day)
RQAP re-registration units: 2 non-GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
The deadline for implementation of the FDA SEND initiative is a little over a year away and many are feeling the pressure to implement and validate a SEND solution. This course will cover the process flow for harmonization, implementation and validation of a SEND solution, including the regulatory requirements covering a SEND compliant submission and potential pitfalls that may be encountered along the way. Emphasis will be placed on points to consider when meeting the expectations of SEND and workshops will allow for open discussion of issues brought forward by attendees.

Objectives
At the end of the course, the participants shall be able to: 
  • Define the regulatory requirements covering a SEND submission.
  • List the elements of a compliant SEND submission.
  • Identify potential pitfalls in the implementation of a SEND solution.
  • Access the tools available for validation of a SEND solution.

Target Audience
Any individual who is embarking on the process of implementing and validating a SEND solution.

Agenda
  • 1. Introduction
  • 1.a. Data processing and data integrity
  • 2. Current status
  • 2.a. Study types included
  • 2.b. Deadlines for implementation
  • 3. Regulatory expectations
  • 4. What is a SEND compliant submission?
  • 4.a. Required data sets
  • 4.b. Standard terminology
  • 4.c. Define file
  • 5. Harmonization
  • 5.a. Activities required to prepare for implementation of SEND
  • 5.b. Data systems (electronic, paper-based, etc.)
  • 6. Validation
  • 6.a. Responsibilities
  • 6.b. Points to Consider
  • 7. Potential pitfalls
  • 7.a. Risk management
  • 7.b Legacy systems
  • 7.c. Resource commitment
  • 8. Summary

Speakers
avatar for Vince D'Angelo

Vince D'Angelo

VP Global QA, Instem
Vince D’Angelo FRQA has worked in the pharmaceutical software industry for over 30 years, including over 20 years’ experience in Computer Systems Validation and is currently VP Global Quality Assurance at Instem plc, who provide pre-clinical and clinical software solutions as... Read More →
avatar for Joe Franchetti

Joe Franchetti

Managing Consultant, JAF Consulting, Inc.
As JAF Consulting Incorporated’s Managing Consultant, Joe Franchetti is an industry leader and teacher for Data Integrity, 21 CFR Part 11, Annex 11, and Computer System Validation in regulated environments. For over twenty-five years, Joe has been involved with the development... Read More →
avatar for Joanne Tyas

Joanne Tyas

Director Quality Assurance, ITR Laboratories Canada Inc.
Joanne Tyas is the Director of Quality Assurance at ITR Laboratories, a pre-clinical contract research organization in Canada. She has over 22 years of experience of working in a GLP environment. Throughout her career Joanne has worked on multiple computer validation projects and... Read More →


Friday April 13, 2018 8:00am - 12:00pm PDT
Platinum 8

8:00am PDT

8:00am PDT

8:00am PDT

Workshop 18 - GCP 201: Advanced Training (1 day)
RQAP re-registration units: 2 GCP, non-GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
This interactive session will provide experienced GCP QA professionals with advanced GCP QA tools to incorporate into how they perform audits, training and GCP support within their roles. This session has been designed to provide best practices and audience participation activities that highlight the experience of the presenters and the attendees.

Objectives
At the end of the course, the participants shall be able to: 
  • Incorporate presented professional development and advanced audit and training techniques into their roles.
  • Incorporate current regulations and guidelines that impact GCP into their roles.
  • Understand and implement a quality management system approach into their roles.

Target Audience
GCP Professionals with 2 or more years of experience.

Agenda
  • 8:00 - 8:30 Welcome, Housekeeping, Agenda Review and Introductions
  • 8:30-9:15 Components of a Quality Management System (QMS) 
  • 9:15-10:00 FDA’s Approach to a Quality Management System Approach in GCPs
  • 10:00 - 10:15 Break
  • 10:15 - 11:00 EU’s Approach to Quality Management System Approach in GCPs
  • 11:00 - 12:00 Practical Application of a Quality Management System (QMS) Approach Within the GCP Arena
  • 12:00 - 1:00 Lunch
  • 1:00 - 2:00 GCP Risk Management
  • 2:00 - 3:00 Root Cause Analysis and CAPA Under GCPs
  • 3:00 - 3:15 Break
  • 3:15-4:30 Additional Strategies for Planning, Conducting and Reporting Audits Under a QMS Approach
  • 4:30 - 5:00 Q&A

Speakers
avatar for Chrissy Cochran

Chrissy Cochran

Director, OBIMO, Food and Drug Administration
Chrissy J. Cochran, PhD is Director of the Office of Bioresearch Monitoring Operations at the FDA, and is responsible for working with each of FDA’s product centers to establish and manage the BIMO program. She previously led the Division of Enforcement and Postmarketing Safety... Read More →
avatar for Glenda Guest

Glenda Guest

President, Assured of Quality Consulting & Training
Glenda Guest CCRA, RQAP-GCP, TIACR has an extensive background in the clinical research industry having worked as a monitor, project manager, data management coordinator, database programmer, quality assurance auditor and senior trainer since joining the clinical research profession... Read More →
avatar for Cheryl McCarthy

Cheryl McCarthy

Associate Director, Biogen
Cheryl McCarthy has over 20 years industry experience in a regulated environment. Her GCP experience includes the development and management of Quality Management Systems, Audit Programs and Computer System Validation Programs. She is currently at Biogen in the role of Associate Director... Read More →
avatar for Vaska Toné

Vaska Toné

CEO / Founder, LaVaPharm Consulting LLC
Vaska Tone is an independent international QA consultant and the founder of LaVaPharm Consutling with offices in the US and Europe. She has been in QA since 1994 performing global audits from GLP through to Post-Marketing PV audits. She is passionate about continual learning and speaks... Read More →
avatar for Lee Truax-Bellows

Lee Truax-Bellows

President, CRO, NCRA
Lee Truax Bellows, RQAP-GCP, CCRALee has an extensive background in the pharmaceutical and medical device industries, having worked for both industry and a CRO as a GCP Quality Auditor, Trainer, and Project Manager. Lee has been involved in regulated research for the past 28 years... Read More →


Friday April 13, 2018 8:00am - 5:00pm PDT
Platinum 1&2

8:00am PDT

Workshop 19 - CSV 203: Auditing in the GxP eData Space (1 day)
RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units

Description
Electronic Data (eData) is pervasive in the GxP world and auditors in that GxP eData space need to understand what is most important in these areas. This course will explore considerations in establishing an eData audit program, give auditors with little Technology/eData/Computer System Validation(CSV)/IT savvy the understanding needed to assess the eData/eSystems they encounter in the course of their existing GxP audits, and expand the understanding of eData auditors beyond the software vendor audit so as to know what is most important in GxP audits. The course will demonstrate "what to look for" for a variety of audits, both technology-focused and more conventional areas in which technology has "encroached."

Objectives
At the end of the course, the participants shall be able to: 
  • Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
  • List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
  • Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
  • Define and list the desired skill set for the eData Audit Team
  • Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported
  • Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.

Target Audience
Seasoned Auditors with little eData/CSV experience or CSV professionals with little auditing experience.

Agenda
  • Establish and differentiate between the eData Audit Function and the Operational CSV Quality Roles.
  • List the considerations for the GxP eData Audit Program (Contributing to other GxP Audits, Independent Focused Data Integrity Audits, etc.)
  • Explore the various roles that the eData Auditor may serve as part of an audit (SME, Co-Auditor, Audit Lead)
  • Define and list the desired skill set for the eData Audit Team
  • Break down the various types of audits and risk areas for each: GLP Labs, Central Clinical Labs, Central Readers (eCG, Imaging, etc.), ePRO (Electronic Patient Reported Outcomes - AKA Diaries), Acquisition Due Diligence, GMP Manufacturing Sites and Vendors, PV, eSystem Validation, Databases, IT Infrastructure, Cloud Providers, Software Providers, SaaS vendors, Pharma, Device, Combo Product, and others.


Speakers
CK

Conrad Kawaguchi

Associate Director, Non-Clinical Quality, Allergan
Conrad Kawaguchi is an Associate Director of Non-Clinical Quality for Allergan’s Global Research Development Quality organization. His responsibilities include overseeing the GLP audit program and inspection activities. He also conducts audits and assessments of GxP regulated software... Read More →
avatar for Timothy Kuhn

Timothy Kuhn

Senior Manager, Global Regulatory Quality, Allergan


Friday April 13, 2018 8:00am - 5:00pm PDT
Platinum 3&4

8:00am PDT

Workshop 20 - General 201: Systems Thinking in Quality Management (1 day)*
*Please note that this is the course that was formerly called "New Perspectives in QA."

RQAP re-registration units: 2 GCP, GLP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
The course provides an opportunity for the QA auditor to learn about systems thinking, system dynamics and related areas and how that knowledge may enrich quality management and lead to a deeper understanding of the nature of QA. The intention of the course is to enhance the effectiveness of the QA auditor's own activities and interactions in QA with peers, colleagues and auditees and to develop and refine QA competence beyond the training of GXP regulatory requirements. The course will consist of short presentations/briefings and discussions, case studies, workshops and exercises where participants are invited to contribute. Participants must be able to communicate fluently in English.

Objectives
At the end of the course, the participants shall be able to: 
  • Understand key features of systems thinking and how they are related to quality assurance
  • Have a selection of new tools and techniques for achieving quality outcomes and building an effective QA function in partnership with their organization
  • Identify activities that will provide the key to future professional and personal development

Target Audience
GXP professionals with some experience in QA (ideally 3 or more years), who wish to learn about new topics related to QA, in particular systems thinking tools and techniques, enhance professional and personal growth and their contribution towards a quality organization.

Agenda
  • The Status Quo
  • Where are we in QA? What's our role?
  • What are the expectations?
  • What keeps us busy?
  • Broadening the Perspective: Systems Thinking and more
  • Key Features of Systems Thinking
  • Systems Thinking and Quality Management – how to combine?
  • More Ideas from Cybernetics, Psychology and Management
  • Putting the new Tools and Ideas to Use
  • Clarifying the Personal Vision
  • Understanding Mental Models
  • Building a Shared Vision
  • Learning as a Team
  • Engaging to add Value
  • The Learning Organization
  • New Roles for QA: Designer, Facilitator, Teacher, Coach
  • Creating a Quality Culture


Speakers
RH

Rita Hattemer-Apostel

CEO/ Consultant, Verdandi AG
Rita Hattemer-Apostel is an expert in Quality Management and Good Clinical Practice Quality Assurance. Since 1994, she has performed more than 700 audits worldwide in all clinical trial areas at sponsors, CROs, laboratories, technical service providers, clinical investigators and... Read More →
avatar for Anthony Jones

Anthony Jones

Executive Director Corporate Quality, Syneos Health
Tony Jones is Executive Director, Quality Assurance for Syneos Health where he has responsibility for QA within the company’s Early Phase operations. Tony has over 30 years of experience in the healthcare and pharmaceutical industries, encompassing clinical chemistry, pharmacokinetics... Read More →


Friday April 13, 2018 8:00am - 5:00pm PDT
Platinum 7

8:00am PDT

Workshop 21 - General 106: Auditor's Primer: Chromatography & Mass Spectrometry (1 day)
RQAP re-registration units: 2 GLP, GCP

*Note: Participants must attend 100% of the training course to receive a certificate of attendance documenting RQAP re-registration units.

Description
Chromatographic and mass spectrometric analyses provide critical data for many pharmacokinetic, dose analysis, safety, efficacy, and absorption, distribution, metabolism, and excretion (ADME) studies. Therefore, it is imperative that quality assurance professionals possess the knowledge and skills to properly audit this type of data. This course contains two distinct, but complimentary sessions. The morning session covers the theory and practice of high performance liquid chromatography (HPLC), ultra-performance liquid chromatography (UPLC), gas chromatography (GC), and mass spectrometry (MS). We will discuss auditing techniques, system suitability testing, incurred sample reanalysis (ISR), and failure investigation. The afternoon session uses a problem based learning (PBL) approach to enhance and hone the quality assurance professional's skills for auditing chromatographic and mass spectrometric data. Participants will be placed into small teams and provided an example data and report packet to audit. We will then discuss the findings as a class. By combining background theory, practice, and applications with hands-on PBL, this course provides an all-around approach to auditing chromatographic and mass spectrometric analyses.

Objectives
At the end of the course, the participants shall be able to: 
  • Identify different chromatographic techniques, their basic theory, and applications in a bioanalytical laboratory
  • Discuss mass spectrometry, its theory and applications
  • Define key chromatographic and mass spectrometry terms
  • Provide guidance on failure investigations
  • Use their newly gained understanding to better audit small molecule bioanalytical data

Target Audience
This course is for any quality assurance professional interested in understanding the science and auditing skills of bioanalytical chromatography and mass spectrometry. It will also cover incurred sample reanalysis and conducting failure investigations. This course is intended for beginner to intermediate level quality assurance professionals.

Agenda
  • Topic Presenter Time (hr)
  • Background (history) and types of chromatography
  • Theory and practice of HPLC/UPLC/GC
  • Auditing chromatographic data
  • Theory and practice of mass spectrometry
  • Auditing mass spectrometry data
  • System suitability
  • Incurred Sample Reanalysis (ISR)
  • Failure investigations
  • Lunch Break
  • Topic Presenter Time
  • Problem Based Learning, Hands-On Exercise


Speakers
avatar for Charlie Kirsch

Charlie Kirsch

QA Auditor II, PPD, Inc.
Charlie Kirsch, RQAP-GLP currently has a position as a QA Auditor II at the PPD, Inc. Bioanalytical Laboratory located in Middleton, WI. After receiving his Bachelor of Science degree from Virginia Commonwealth University, he began his career in Richmond, VA at PPD, Inc., in 2009... Read More →
avatar for Deborah Parker

Deborah Parker

QA Manager, ICON Bioanalytical Laboratories
Deborah Parker is a QA Manager at ICON PLC. She has over three decades of experience in the pharmaceutical industry, with training as a bioanalytical scientist. Having performed analysis using RIAs, Enzyme Inhibition testing, ELISAs, HPLC and LC-MS/MS, her background provided a perfect... Read More →
avatar for Steve Rogenthien

Steve Rogenthien

Director, Quality Assurance, Concord Biosciences/Frontage Laboratories
Mr. Rogenthien is the QA Director at Concord Biosciences, LLC (formerly Ricerca Biosciences) where he oversees the quality programs that support the company's drug safety & metabolism, bioanalytical, and agrochemical product development departments. Prior to joining Ricerca in 2007... Read More →
avatar for Kim Wheeler

Kim Wheeler

QA Manager, PPD
Ms. Wheeler started in GLPs in December of 1980 at A.H. Robins Research. She has over 10 years’ experience in analytical method development in GLPs /GMPs, having worked for Robins Research Division and Sergeant’s Pet Products.Kim Wheeler is a MLT-AD, ASCP, and managed a hospital... Read More →


Friday April 13, 2018 8:00am - 5:00pm PDT
Platinum 9

10:00am PDT

Quality College Beverage Break
Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)
Assorted Soft Drinks (Pepsi Products)
Bottled Water

Friday April 13, 2018 10:00am - 10:15am PDT
Platinum 5

12:00pm PDT

Quality College Networking Lunch
Deli Market Buffet
California Garden Salad with Herb Ranch Dressing and Shallot Vinaigrette Orzo Salad with Sundried Tomato, Artichoke and Basil
Vegetable Wrap – Portobello, Roasted Peppers, Asparagus and Arugula, Chipotle Aioli Roast Beef, Ham, Salami and Honey Roasted Turkey
Peppered Jack, Havarti, Cheddar and Swiss Cheeses Red Leaf Lettuce, Sliced Vine Ripe Tomatoes and Pickles
Cranberry-Horseradish Sauce, Tarragon Mayonnaise, Grey Poupon Mustard Kaiser Rolls, Sourdough and Whole Grain Sliced Bread
House- Made Chips
Chef Selection for Dessert
Starbucks Coffee, Decaffeinated Coffee and Selection of Tazo Tea (to include soy and almond milk)
Iced Tea

Friday April 13, 2018 12:00pm - 1:00pm PDT
Platinum 5

3:00pm PDT

Quality College Beverage and Snack Break
Individual Bags of Assorted Popcorn Assorted Soft Drinks (Pepsi Products) Bottled Water
 Starbucks Coffee, Decaffeinated Coffee and Tazo Teas (to include soy and almond milk)

Friday April 13, 2018 3:00pm - 3:15pm PDT
Platinum 5