Implementing Risk-Based Verification and Validation

Implementing Risk-Based Verification and Validation

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

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

But like any basic change, there’s a learning curve. Are you ready?

Not to worry — help is at hand.

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.

Your guide, 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 in your operation. You'll 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 you on the FDA’s good side. You’ll have to make the switch sooner or later. Why not start now? Order your copies of Implementing Risk-Based Verification and Validation.

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.
Suggested 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

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