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FDAnews Management Report: Implementing Risk-Based Verification and Validation
Date:12/19/2013

Falls Church, VA (PRWEB) December 19, 2013

Implementing Risk-Based Verification and Validation
**FDAnews Management Report**
http://www.fdanews.com/RiskBased

Switching to risk-based verification and validation is likely to save drug and devicemakers money on projects, plus reduce liability and recalls.

It’s a good business idea. And what’s more, the FDA is pushing companies to do it.

But like any basic change, there’s a learning curve.

This all-new management report from FDAnews is just the ticket for drug and device manufacturers ready to take the first step … and seeking a helping hand.

The author, consultant John E. Lincoln, has more than 30 years of experience assisting drug and device manufacturers to design new products, pilot them, set up production, validate and bring them to market.

Implementing Risk-Based Verification and Validation begins with the basics — understanding what risk-based V&V is — then shows how to start implementation. Readers will discover:

  • Validation and verification basics
  • Master validation planning and product risk
  • Design qualification, installation qualification, operational qualification and performance qualification
  • Software validation and verification under 21 CFR Part 11
  • Product life cycles and validation
  • Quality System Regulation under 21 CFR 820 and ISO 13485
  • And much more

When FDA-regulated companies fail to do the basics of V&V, warning letters and Forms 483 often follow. Shifting to risk-ba
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