Medical Device Current Good Manufacturing Practices

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Level: Beginner
Lecture Hours: 16.00
Lab Hours: 0.00
Total Contact Hours: 16.00
Currently Offered


Learn the principles, requirements, and expectations of Current Good Manufacturing Practices (CGMP) for medical device production. Topics covered include the regulatory definition of what constitutes a medical device, the division of the FDA responsible for medical device applications and compliance, and how the risk-based regulatory categorization of medical devices affects the scope of applicable CGMPs.