William H. Shackelford MS, RAC, ASQ-CQIA
Consumer Safety Officer
Office of Medical Device and Radiological Health Operations
This presentation is the sequel to our popular February FDA presentation, diving into additional topics. This presentation will elaborate on the FDA’s medical device inspection methodology from the viewpoint of an investigator, on the regulations involved in a typical medical device inspection, and on typical audit findings related to In-Vitro Diagnostic Devices (IVDs). Building quality aspects into medical devices will be covered.
6:00 – 6:30 PM – Networking Time/Announcements
6:30 – 7:30 PM – Talk, Q&A
7:30 – 7:45 PM – Door Prizes/Survey
0.5 RU’s will be awarded to ASQ members for attendance
After registering, you will receive a confirmation email containing information about joining the webinar.
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