is being presented by Vinny Sastri, President, of Winovia LLC and airs on Tuesday, December 14th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Why does a significant percentage of all warning letters for medical devices and pharmaceuticals continue to be CAPA-related even though critical thinking and problem solving methodologies proliferate in the industry? In November 2009, the Global Harmonization Task Force (GHTF) issued a draft, proposed guidance document that provides the latest thinking and approach of the regulatory bodies on CAPA. This includes the use of risk-based processes and decisions.
This audio conference discusses how to use risk-based decisions in implementing, prioritizing and conducting CAPA projects and processes. In addition it provides organizational best practices to enable effective CAPA systems.
