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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:
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?
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