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