Why is FDA at my facility, and what do I do during an inspection

This two day course will prepare firms for a quick, productive, and efficient FDA inspection. Included are segments on FDA Law, how to prepare for the inspection, how to prepare your subject matter experts (SMEâs) to respond properly, and how to respond to an FDA 483 or Warning Letter. Case Studies and Templates are included.This course begins with a high level discussion about why FDA conducts inspections and the sanctions available to FDA for those companies who choose not to comply with FDA requirements. Next, we cover what to expect during the inspection, including how to communicate with the investigators, run your front and back rooms, and present documents and records. We cover doâs and donâts, choosing your core inspection team, facilitators, Subject Matter Experts (SMEâs), runners and scribes.
Highlights
Legal Obligations, FD&C Act and 704(a)(1), Right to Inspect, Case Law - Real Life Examples
FDA Enforcement, Management Responsibility from FDA’s View, FDA Inspection
SME Training and FDA-483’s / Warning Letter Responses, FDA Interviews
How To Get The Best Out of The Inspection, Replying to FDA-483’s and Warning Letters
Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements.
Entry Fee
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