Does any one have FDA 21 CFR Part 820 QSR training material?

A

andy.yuan

#1
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
 

yana prus

Involved In Discussions
#3
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
 
Last edited by a moderator:

amjadrana

Involved - Posts
#4
This link from the FDA website has a lot of training videos along with presentation on many regulatory subjects including a 105 minutes video on QSR.

http ://www .fda. gov/Training/CDRHLearn/ucm162015.htm - DEAD (404) LINK DELINKED
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Super Moderator
#6
So sorry so many links to the FDA website are broken...
The FDA's Quality Systems Manual was withdrawn years ago (so there's no current substitute to link to).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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