Medical Device GMP
PD631847
- Content
The FDA requires employees to be trained in the current GMP as it relates to the employee's functions to help assure the safety and efficacy of medical devices.
- Content
- Understanding regulatory framework: Gain a thorough understanding of the regulatory framework governing GMP requirements for medical devices, as outlined by the Quality System Regulation (QSR) in Title 21 CFR Part 820.
- Compliance with CGMP requirements: Learn how to interpret and comply with the specific requirements outlined in the QSR, which govern the methods, facilities, and controls used in the design, manufacture, packaging, labeling, storage, installation, and servicing of finished medical devices intended for human use.
- Content
This is course is for professionals working in the medical device manufacturing industry, as well as quality assurance and regulatory compliance inspectors.
- Duration
- 12:00