How to Prepare for a US FDA Drug Establishment Inspection
Get In Touch with a Regulatory Expert: https://www.registrarcorp.com/contact... Follow us on social media: / registrar-corp / registrarcorp X / https://x.com/registrarcorp FDA inspections are inevitable for drug manufacturers — whether to secure pre-approval for a new product, ensure GMP compliance, follow up on post-market reports, or investigate complaints and recalls. While the reason may differ, FDA investigators follow established procedures, and knowing what to expect can make the difference between a smooth inspection and a disruptive one. In this webinar, Larry Stringer, Former FDA Supervisor and Investigator with more than 30 years at the U.S. Food & Drug Administration, will share first-hand insights from conducting hundreds of inspections and leading revisions to FDA’s Investigations Operations Manual (IOM) — the primary reference for field investigators. You’ll gain a clear understanding of how investigators approach inspections, what they are evaluating, and — most importantly — how your team can prepare and respond to protect your operations. Key Questions Answered 1. What does the investigator do before arriving on site? 2. Why is FDA inspecting my facility? 3. What are the limits of an inspection? 4. What happens during the inspection? 5. What does the investigator do afterward? 6. What should you do once the inspection is complete? 7. How can you prepare in advance to minimize risk? 0:00 Introduction 4:47 What happens before the inspection? 6:49 Why is FDA inspecting my facility? 8:47 Are there limits to an inspection? 13:31 What happens during an inspection? 33:31 What happens after an inspection? 43:02 What can I do to prepare? 49:26 Q&A
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