FDA Compliance 2011 - Incorporate FDA's New Process Validation Principles into Company Verification and Validation Planning

Learn how to incorporate key principles of the FDA's new Process Validation guidance in creating a Master Validation plan, evaluate its elements against ISO 14971, ICH Q9 for hazard analysis and risk management, and understand how to employ DQs, IQs, OQs and PQs.

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.

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.

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 4th December 2011.