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.
All personnel working in the medical device industry including:
- Manufacture /Production Operators
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance and Engineering Personnel
- 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.
- Explain the regulatory definition of medical devices
- Describe the FDA regulation of medical devices
- Identify aspects of FDA oversight
- Discuss Quality Systems Regulations
- Compare and contrast ISO 13485 and QSR
- Discuss the mechanics of ISO certification
- Implement Good Documentation Practices
- Search the FDA website and resources
Delivered in-person in a classroom or lab setting.
Delivered online with a live instructor at a scheduled date and time.