Process Verification and Validation Planning and Execution

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in big name device and pharma companies. And now the FDA is taking an even tougher stance. One major failing is lack of sufficient or targeted risk-based V&V planning. Why do companies need a Master Validation Plan? What are the must have elements from ISO 14971 and ICH Q9 for hazard analysis and product risk management? How can these be integrated into a company's quality management system.

Areas Covered in the Seminar:

• Process Validation -- New regulatory expectations.
• Adjusting the Master Validation Plan.
• Product, Process / Equipment V&V.
• When and How to Use DQ, IQ, OQ, PQ.
• Using the Risk Management tools of ISO 14971 and ICH Q9.
• The 11 Elements of the Software VT&V "Model".
• Avoid recent "horror stories" and multimillion dollar fines.