Implementing Risk-Based
Verification and Validation

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?

 

PDF Edition — $397

Print Edition — $397

 

 

Available Format
PDF Edition — $397
Print Edition — $397
Table of Contents
  • Verification and Validation Basics
  • Master Validation Plan
  • Risk-Based Validation Planning
  • Individual Validation Plans

View the entire TOC

Multi-user Access

Save money with a license agreement allowing significant numbers of users access to an electronic version of this book. For multi-user access to multiple titles, FDAnews offers the FDAnews Online Library — a personalized collection of FDAnews publications that is fully searchable. Contact Customer Service for a quote or more information.

Our Guarantee

Not satisfied with your publication? For the PDF version, you must notify FDAnews within 24 hours of receipt of purchase and we will refund 100 percent of your purchase price.