FDA Issues Long-Awaited Quality System Regulation Amendment

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Wednesday, March 16, 2022
12:00 PM - 12:30 PM ET
11:00 AM - 11:30 AM CT
09:00 AM - 09:30 AM PT

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.