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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.
Sunday, April 8 • 8:00am - 5:00pm
Workshop 2 - GCP 101: Understanding the Basics (2 days)

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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
Platinum 3

Attendees (8)