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          Quality - Regulatory 

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Our "Quality - Regulatory MEDICAL DEVICE NEWS", formally a hardcopy bi-monthly newletter, is now published as a monthly e-zine, and available at no charge upon e-mail request.

Copyright 2006, J. E. Lincoln and Associates. All rights reserved.

May be copied / forwarded without written permission, but with attribution.

                                                                      

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J. E. Lincoln and Associates

P. O. Box 154 435-882-4655

Tooele UT 84074-0154 888-882-4655

www.jelincoln.com jel@trilobyte.net

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Now available by request:

Quality - Regulatory MEDICAL DEVICE NEWS E-Zine

September 2006 Vol. 10 No. 10


V&V Planning Q&A


Key points:

o Master Validation Plan

o Gauge R&R's

o Supplier V&V

o Visual Inspection

o Variables in the OQ

o Risk with Unknown End Use


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                                        Last updated on 10/03/2006.