US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
Website https://www.complianceonline.com/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system- |
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Deadline: May 29, 2021 | Date: June 08, 2021
Venue/Country: U.S.A
Updated: 2021-04-25 04:31:29 (GMT+9)
Call For Papers - CFP
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 development, production, installation, documentation, and servicing. Also: the Quality Management System, Management Responsibility, Managing Resources, Planning, Design and Development / Control, Change Control, Purchasing, Production, and Monitoring, Analysis, and Improvement.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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