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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