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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.
This course may be taught at any location.
- Introduction, FDA and Enforcement
- Medical Device Regulatory Guidance Overview
- Medical Device Registration
- Investigational Device Exemption Regulations
- Medical Device Regulations (21 CFR 820)
- Medical Device Recalls and ISO
- Buildings and Facilities
- Production and Process Controls
- Safety Alerts
- Products and Medical Procedures
- Medical Device Safety
- Combination Products
- Understand the need for and processes for regulation and enforcement of medical devices.
- Gain an understanding of the reasons for producing safe and effective products using cGMP.
- Understand the consequences of failing to produce safe and effective products.
Any employee that works or wants to work in the medical device industry.