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Clinical Trial Events
MAGI

Talk Quality / Regulatory track

FDA Inspections: Always Be Ready and What to Do When They Actually Come Knocking on Your Door!

Sun, May 18, 2025 · 11:00 AM–1:00 PM EDT Sheraton Boston Hotel

About this session

Learn from other people's mistakes: Common findings from 483s, FDA warning letters, and trends. Learn from the Compliance Program Guidance Manual: Instructions for conducting FDA inspections. Before, during and after inspection: What you need to know and what you need to do to prepare

Speakers

  • Kaitlin Gillette

    Associate Director, Clinical Operations · Syneos Health

    Speaker

  • Paul Papagni

    AVP, Center for Research · Baptist Health South Florida

    Speaker