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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
 Special Processes
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| Author | Topic: Special Processes |
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Wallybaloo Forum Contributor Posts: 16 |
posted 10 July 2000 05:02 PM
   
Does anyone have any information about the FDA's 'new' position on special processes and process validation? I've been counting on the GHTF Process Validation Guidance document that allows for accepting processes producing low risk parts without the necessity for validation. Now I read (see Letters to the Editor, RAPS magazine FOCUS, July 2000) that, apparently, the FDA may require process validation for all special processes. While I realize the value of validation in many instances, there are those times that the nature and history of the part makes it unnecessary. Any insight here? Thanks. IP: Logged |
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