Understanding of Fda 21 Cfr Part 820 – Quality System Regulation
Medical device establishments with products intended for use in the United States must register their establishments and list their products with FDA. Understanding US FDA CFR Part 820 can help medical device establishments meet FDA Guidelines like registration and listing, UDI and GUDID requirements, and preparing the Medical Device Master files.
This course is designed for ALL functions and levels of an organization who need to gain some basic understanding of the US FDA 21 CFR Part 820 requirements. A value-added course for those working with US regulatory compliance and involved in regulatory inspection.
help organizations understand and comply with the Quality System Regulation (QSR) as outlined by the U.S. Food and Drug Administration (FDA) in 21 CFR Part 820. All relevant employees are aware of and understand the requirements of Part 820 so that the organization can maintain high standards of quality and regulatory compliance.
Overview of the FDA and intention of the 21 CFR Part 820
The requirements of 21 CFR Part 820 and other relevant Parts such as Part 11, Part 803, and Part 821
Working knowledge in application of the requirements
Preparation and host an FDA inspection
- This course is designed for anyone who may involve in the implementation and execution of this Quality System Regulation
- This course can be run in-company around the world
- We can tailor the content to focus on your requirements.
- This approach makes perfect sense for groups of 4+ delegates, enhancing cost effectiveness as well as team bonding.
- Classroom accompanied by Lectures, real Experience Sharing, Role-plays, Interactive Group Activities, Experiences, Simulation Activities and Feedback
- Delegate manuals and certificates of Attendance will be provided
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