FDA Issues Long-Awaited Quality System Regulation Amendment

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Wednesday, March 16, 2022
12:00 PM - 12:30 PM Eastern Daylight Time
11:00 AM - 11:30 AM Central Daylight Time
09:00 AM - 09:30 AM Pacific Daylight Time

In this session, FDA partners Dennis Gucciardo and Michele Buenafe will discuss the long awaited proposed rule for amending the Quality System Regulation to be harmonized with ISO 13485:2016, and what it may mean for regulated firms.