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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 FDA
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| Author | Topic: FDA |
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Lee Clermomnt unregistered |
posted 04 January 2001 10:53 AM
 
Does anyone have a good audit form or know where I can obtain one that covers FDA regulations and GMP's. leeclermont@hotmail.com IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 13 January 2001 02:55 AM
 
Unfortunately Don is on Sabattical. I don't have one off hand but would be interested as well. IP: Logged |
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Karen Browne unregistered |
posted 06 February 2001 03:04 PM
If you are talking GMP's for devices, then a good place to look is: www.fda.gov/cdrh/index.html From there go to "Topics" then "Q" and scroll to Quality Systems. There you will find the QSIT (Quality Systems Inspection Technique) guidance. This is what FDA is using for their inspection "template". Along with other good info is the 'Quality System Regulations' (QSR or cGMP's) posted there as well. I do not use a specific form, however, I have put a table together that cross references the ISO and QSR requirements so we make sure all bases are covered during internal audits. Hope this helps. IP: Logged |
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