CGMP Overview for Medical Devices

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.

Audience

All personnel working in the medical device industry including:

Manufacture /Production Operators
Quality Control Personnel
Quality Assurance Personnel
Maintenance and Engineering Personnel

Topics Include

Regulatory definition of medical devices.
Overview of medical device product types
The FDA’s role and responsibilities in the regulation and oversight of medical devices
- Regulatory history
- Device classification system
- Clearance process and inspection
- Enforcement
Comparison of 21 CFR 820 (QSR) to ISO 13485.