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  FDA and Medical Devices
  Internal Audit for FDA

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Author Topic:   Internal Audit for FDA
Marc Smith
Cheech Wizard

Posts: 4119
From:West Chester, OH, USA
Registered:

posted 03 February 2000 03:23 PM     Click Here to See the Profile for Marc Smith   Click Here to Email Marc Smith     Edit/Delete Message   Reply w/Quote
On 2/3/00 2:44 PM, [email protected] wrote:

> Dear Marc,
>
> I am a Process Quality Engineer working for xxxx in xxxx. We are an
> Oxygen Therapy Business that manufactures respiratory
> products for the home and hospitals.
>
> I was reading comments about a process audit in Arters thoughts on the
> Internal Audit subject within the forums and would greatly appreciate your
> inner thought on how to put together an audit program for "New Manufacturing
> Processes" as asked of me by my Quality Manager.
>
> I was mainly concerned with a starting point for our current internal audit
> program compliant with ISO 9002, GMP (Part 820.22) and also covering FDA
> requirements.
>
> I believe my manager is looking for keys areas to point out in conducting a
> "New Manufacturing Process".
>
> Any help would be greatly appreciated.
>
> Thanks,
> XXXXX

Personally I would form a Requirements Matrix to match against existing procedures and from the referenced procedures form an audit plan/schedule.

Don will probably have better info than I do in identifying 'key' areas. How about it, Don?

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