Dear friends,
I'm a freshman in FDA 21CFR 820QSR, Does any one have the training mateiral or detailed explanation for this regulation? I need this urgently.
I really appreciate your help.
Million thanks.
Regards,
Andy
you can start with very practical and comprehensive Medical Device Quality Systems Manual - A Small Entity Compliance Guide
http ://www .fda. gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/MedicalDeviceQualitySystemsManual/default.htm - DEAD (404) LINK DELINKED
The FDA's Quality Systems Manual was withdrawn years ago (so there's no current substitute to link to).
CDRH Learn still has a lot of relevant materials. I'd just go there and browse / search. CDRH Learn
In general, FDA has announced in 2018 that it plans to move away from its own QSR/cGMP/part 820 and towards ISO 13485:2016. The transition is likely to begin late 2019 and last 2-3 years.
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