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The Annual Meeting program is subject to change. Speakers are added as confirmations are received.
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Sunday, April 8 • 8:00am - 5:00pm
Workshop 1 - GLP 101: Basic Training (2 days)

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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
  QC Workshop, QC Workshop - 2 Day

Attendees (10)