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FDA 21 CFR 820 QSR Quality Manual example wanted
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FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
FDA 21 CFR 820 QSR Quality Manual example wanted
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  Post Number #1  
Old 28th November 2009, 05:57 PM
santhosh741

 
 
Total Posts: 14
Let Me Help You FDA 21 CFR 820 QSR Quality Manual example wanted

I am developing a quality manual for a small device company and which is strictly aligned to 21 CFR 820 QSR. I would appreciate any sample quality manuals, SOPs and other procedures based on the same.

Thanks

Last edited by santhosh741; 28th November 2009 at 06:01 PM. Reason: for clarity

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  Post Number #2  
Old 28th November 2009, 08:16 PM
harry

 
 
Total Posts: 6,291
Re: FDA 21 CFR 820 QSR Quality Manual example wanted

We have a copy in the 'post attachments list'. Just do a search with 'manual' as keyword.

Link

Last edited by harry; 28th November 2009 at 08:18 PM. Reason: add link
  Post Number #3  
Old 28th November 2009, 08:16 PM
achorste's Avatar
achorste

 
 
Total Posts: 200
Re: FDA 21 CFR 820 QSR Quality Manual example wanted

Clinivation do a template at the downloads page:

http://www.clinivation.com/pages/res.../downloads.php

You do have to register but it's free.
  Post Number #4  
Old 28th November 2009, 11:38 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,205
Re: FDA 21 CFR 820 QSR Quality Manual example wanted

Quote:
In Reply to Parent Post by santhosh741 View Post

I am developing a quality manual for a small device company and which is strictly aligned to 21 CFR 820 QSR. I would appreciate any sample quality manuals, SOPs and other procedures based on the same.

Thanks
Just to check with you - do you have an ISO 13485 manual ? If yes, you could have the same with a table referencing the 21 CFR Part 820 elements in a tabular form.

Refer this Quality Manual as an example.
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #5  
Old 29th November 2009, 10:42 AM
santhosh741

 
 
Total Posts: 14
Re: FDA 21 CFR 820 QSR Quality Manual example wanted

I appreciate all for your guidances and links.
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