This course provides an overview of medical device current Good Manufacturing Practices (cGMP), with a focus 21 CFR 820, and the systems to ensure proper design, monitoring, and control of the manufacturing processes and facilities. Topics include the criteria for what constitutes a medical device, a brief overview of the risk classification of medical devices, management’s role in the implementation of cGMP’s, and the importance of good documentation practices. Additional topics introduced include Product Design, Verification, Validation, and Risk Management, and consequences of Product Failures and related outcomes.
Participants in this course will learn:
• Current Good Manufacturing Practices (cGMPs) for medical devices
• The criteria for what constitutes a medical device
• An overview of the risk classification for medical devices
• The role of management in implementing cGMPs
• The importance of good documentation practices
This course is available online, and can be taken anytime, anywhere.