FDAnews Management Report: Implementing Risk-Based Verification and Validation

When FDA-regulated companies fail to do the basics of Verification and Validation, warning letters and Forms 483 often follow. Shifting to risk-based V&V helps keep them on the FDA’s good side.

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Implementing Risk-Based Verification and Validation

Implementing Risk-Based Verification and Validation

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-based V&V helps keep drug and devicemakers on the FDA’s good side. All companies have to make the switch sooner or later. Why not start now? Order Implementing Risk-Based Verification and Validation.

About the Author:
John E. Lincoln is a partner at J.E. Lincoln and Associates. With a background in engineering, R&D, manufacturing, QA and regulatory affairs, he has more than 30 years of working in FDA-regulated industries under his belt. His experience includes designing, piloting, setting up production, validating and bringing drugs and devices to market.

Who Will Benefit:
Here’s a suggested list of potential readers:

  • Validation specialists
  • QMS managers
  • Product/Process/Equipment managers
  • Product/Process/Equipment testers
  • Computer system operators
  • GMP auditors
  • Project managers
  • Risk managers
  • Compliance officers
  • Training personnel
  • Service providers
  • Software developers

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

Format: Print or PDF
Price: $397

Easy Ways to Order
Online: http://www.fdanews.com/RiskBased
By phone: 888-838-5578 or 703-538-7600

ABOUT FDANEWS
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.


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