April 16, 2008

Biomedical Discussion Group
Managing Risk using ICH Q9 & ISO 14971

( Meeting / Speaker Info )      ( Date & Time )        ( Location )     ( Directions )     (Cost )    

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Mike Wakshull


Risk management is a component of a quality management system. Implementing ICH Q9 (Quality Risk Management) for pharmaceutical products and ISO 14971:2007 (Risk management for medical devices) are recommended guidance. Used together, the standards complement each other, creating a powerful approach to managing risk for the life of the product.

ABOUT THE SPEAKER
Mike Wakshull has more than 15 years experience in the risk management field in a variety of industries including biotechnology, financial, information technology and airport. He is the president of Q9 Consulting, Inc., a contract provider of risk management services that include training and development of quality risk management processes.

Meeting Date :
April 16, 2008 at 6:00pm

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