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
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.
How to order:
Mention priority code 13D11 when registering.
- Order online.
- Call toll free 888.838.5578 (inside the U.S.) or 703.538.7600. Use your American Express, Visa or MasterCard.
- Fax your purchase order to 703.538.7676.
- Mail your check to: FDAnews, 300 N. Washington St., Ste. 200, Falls Church, VA 22046-3431.