This continually updated course covers current FDA regulatory compliance with respect to developing medical devices. A focus will be placed on basic regulation and the FDA's supplemental guidelines.
Among the topics to be discussed are: context of design control within the overall quality system and regulation, design control procedures, forms, records, safety/risk management strategies, documentation strategies, manufacturing transfer strategies, and strategies for integrating general quality system procedures into design control.
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This course will be most valuable to medical device industry engineers, engineering managers, regulatory affairs professionals, scientists, and quality engineers needing an understanding of Design Control per the FDA's CFR 820.30. The course also . . .