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

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
The entry point is https://www.fda.gov/media/82916/download.

For the QSR presentation materials, peruse

Overview of the Quality System

Start Here! Overview of the Quality System (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Production and Process Controls (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Documents, Change Control, and Records (New module 11/19/18)
PresentationExternal Link Disclaimer Printable Slides Transcript

Design Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Management Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Purchasing Controls
PresentationExternal Link Disclaimer Printable Slides Transcript

Process Validation
PresentationExternal Link Disclaimer Printable Slides Transcript

Corrective and Preventive Actions
PresentationExternal Link Disclaimer Printable Slides Transcript

Nonconforming Product
PresentationExternal Link Disclaimer Printable Slides Transcript

Complaint Files
PresentationExternal Link Disclaimer Printable Slides Transcript
 

blah01

Involved In Discussions
#13
Does part 820 (or eventually ISO 13485) apply to Class I devices?
So to answer my own question from an earlier post if Part 820 applies to Class I devices, the answer is ...it depends...

Per the "Medical Device Exemptions 510(k) and Device Listing" page (link), it identifies Class I devices that are GMP (i.e. Part 820) exempt, which depends on the product sub-category. You basically have to figure out your product category and sub-category and look up the details on that sub-category and it will indicate if it is GMP exempt or not. For example, 886.5910 is GMP exempt.

Just posting this in case it helps anyone.
 
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