Medical Devices 2011 - Risk-Based Verification and Validation Planning to Meet U.S. FDA, ICH Q9 and ISO 14971

Why Should You Attend:

FDA Warning Letters and recent high-profile recalls indicate major cGMP deficiencies in many companies. 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.

Attend this Webinar to know how to review a company's Master Validation Plan for major cGMP deficiencies. How to address the FDA's newer and tougher regulatory stance. How to create a Master Validation Plan, evaluating its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management and develop meaningful product and process validations. Also the roles of different V&V protocols; how to employ equipment / process DQs, IQs, OQs, and PQs, against a background of limited company resources. A matrix simplifies "as-product", in-product", process and equipment, et al, software VT&V, assuring key FDA requirements are not overlooked. The QMS and 21 CFR Part 11 will be discussed.

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