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

(complianceonline.com)

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.

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

Tags

  • Risk Based Verification and Validation, FDA GMP Requirements, ICH Q9, ISO 14971 Requirements, Master Validation Plan, V&V planning, V&V protocols

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