Current Good Manufacturing Practices for Medical Devices
Good manufacturing practices are the regulations enforced by the United States Food and Drug Administration (FDA) for medical devices. They are often referred to as current Good Manufacturing Practices (cGMP’s), and provide the systems and the framework to assure proper design, monitoring, and control of manufacturing processes and facilities. This course will provide an overview of medical device cGMP’s. You will also gain knowledge of what constitutes a medical device, a brief overview of the risk classification of medical devices, managements role in the implementation of cGMP’s and the importance of good documentation practices.
This course is available online, and can be taken at your own pace.
Please note: You must complete the course within 3 months of registration.
- Lectures 0
- Hands-On Training 0
- Duration 3 hours
- Skill level All levels
- Wet Lab No
- Max Students 75
- Assessments Yes