SvenskaCurrent 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
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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
|
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| 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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