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Friday, April 13 • 8:00am - 12:00pm
Workshop 22 - GLP 102: History Behind the FDA GLPs (1/2 day)

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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.

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.

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.

  • 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

avatar for Barbara Munch

Barbara Munch

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

Attendees (1)