When: |
01 Mar 2022 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system-webinar-training-705794-prdw?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Education / Legal / Other - Education |
Keywords:
Event description:
Learn the basic overview of the original medical device Quality Management System -- The US FDA’s CGMP, Quality System Regulation (QSR) under 21 CFR 820. Implementation, training requirements and content, and annual internal audit / inspection expectations. The FDA’s four key areas of compliance under QSIT.
Why Should You Attend:
In the U. S., the Quality System (QS) Regulation (21 CFR Part 820) governs the manufacturing of medical devices, the device CGMPs. What is the importance, and purpose, and the framework of basic requirements for design and manufacture of medical devices, as well as a summary of the key requirements, the 15 subparts, terms, and the underlying purpose for the requirements under the Device CGMPs? How is a company’s quality management system “established / implemented and maintained under this Quality Management System (QMS)? Major discussion points: Regulatory requirements that apply to the methods, facilities and controls used for device design and deve...
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Posting date:
01 February 2022 | 375 views
Placement:
Not-featured (How do I make my event featured?)