Current Good Manufacturing Practice - FDA, USA 21 CFR part 820 Quality System Regulation

Course length
1 day

Schedule
Each day 08:30 – 16:30 (8.30 a.m. - 4.30 p.m.)

Facts

Background	For marketing of medical devices in USA, each manufacturer must comply with the requirements of 21 CFR 820 (Quality System Requirements) during the development, manufacturing, quality control and distribution processes.
Scope	Participants will get detailed knowledge about the requirements of 21 CFR 820 QSR
Intended for	The course is intended for managers and supervisors in executive management, product development, sales and marketing, manufacturing, quality control, distribution, service and any other function being involved with the FDA requirements for medical devices and diagnostic products.
Contents	Background for regulatory requirements for medical devices Getting a new medical device to the US market Food and Drug Administration (FDA) FDA Inspections outside USA QSR – overview of requirements Detailed requirements and comparison with ISO 9001 and ISO 13485 Workshop Discussion, questions and answers
Program	The course is conducted as lectures and workshops including discussions where each participant is activated.
No of participants	Maximum 16
Qualification test	Upon request
Documentation	Provided by PREVENTIA AB. The documentation contains copies of slides, regulatory texts and guidelines.

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