This course provides an overview of the Food and Drug Administration
(FDA) principles, requirements, and expectations for compliance with the
Current Good Manufacturing Practices (CGMPs) related to medical device
manufacture. Discussions of ISO standards and their application to the
marketing of medical devices include an introduction to ISO
certification and the similarities to Quality Systems Regulations (QSR).
The importance of Good Documentation Practices with respect to CGMP
compliance will be stressed. FDA enforcement and consequences of
non-compliance will be addressed.