[Hidden-tech] Biopharm/Medical Device Validation Consultant

[Tom Gajda]

Hi,
 
One of my customers will be making and selling equipment that will be used
to make medical devices.
 
The customer is looking for a consultant that can educate them about the FDA
validation and documentation requirements.
 
While I have eight years of experience writing SOPs, FATs, IQs, OQs, PQs,
validation guides, quality policy manuals, site master file, etc. in the
biopharm industry, I do not feel I am the seat of authority that my customer
needs for this high-level planning phase. I am close, but not quite.
 
I have been a business partner with this customer for about three years, and
I expect to help them develop and write the validation documentation once we
know what the specific requirements are.
 
So obviously I would want to connect with someone who will not compete with
me but provide the high-level guidance the customer needs: at least a
presentation to management on what is required, and perhaps the development
of a moderately-detailed plan.
 
If you or someone you know is qualified in this area, please contact me.
 
Regards,
 
Tom  
 
Tom Gajda
Engineering Writer
Thomas Paul Communications, LLC
413-297-2246 |  <http://www.engineeringwriter.com/>
www.engineeringwriter.com
 
www.processequipmenttraining.com
www.engineeringwriter.com
 
 
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