Center for Professional Innovation & Education, Inc., Los Angeles, CA
Mar. 17 & 18, 2014
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.
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