21 CFR 820 contains the FDA’s requirements for Quality Management Systems. These requirements have been around a long time (since Jul 1978). FDA is now proposing to amend this regulation to align more closely with QMS requirements used by other global regulatory authorities. The purpose of this presentation is to familiarize attendees with the proposed changes.
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Speaker
Michael Checketts is a veteran of 40+ years in the medical device industry, working for both OEM’s and 1st tier suppliers. He has managed operations, engineering & QA/RA functions for both start-up and legacy product manufacturers. Now as a consultant for Omnex, Michael has shown proficiency in ISO 9001, 13485, 14001, 14971, 17025, 62304 and of course 21 CFR 820 and the EU MDR’s. He has lead course instruction and is a certified lead auditor in all these areas.