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 Organizer Venue
sports
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08/02/2020 Last update