There is a failure to thoroughly investigate unexplained discrepancies…
Has your organization received this feedback in an FDA Form 483? If yes, get expert advice to further develop deviation writing and investigation skills at the 2023 PDA Mastering Deviations Workshop!
In this workshop, participants will learn how to:
- write effective deviation reports that meet regulatory requirements;
- develop a defined process for classifying deviations, and learn how to develop of a compelling story (yes, deviations are storytelling!);
- develop a toolkit for investigators; and,
- accelerate investigations from start to finish.
PROGRAM PLANNING COMMITTEE
- Tita Tavares, PDA (Chair)
- Frederic Ayers, Valsource, Inc.
- Julie Barnhill, Meridian BioGroup - Pace Life Sciences
- Jamie Bastien, Bristol Myers Squibb
- Gerardo Gomez, PharmaLex
- Martin Jenkins, Circle MJ Consulting
- Kate Malachowski, Novavax
- Katie Masterson, REGENXBIO
- Megan Matthews, Emergent BioSolutions