Comprehensive CAPA Investigations - Continuous Improvement and Regulatory Compliance
|Event Date/Time: Jun 24, 2009||End Date/Time: Jun 24, 2009|
|Registration Date: Jun 24, 2009|
In this seminar participants will learn FDA cGxP CAPA techniques for analyzing and incorporating information from disparate sources into solid investigations suitable for implementing sustainable action and for FDA review.
Executed and documented well, a comprehensive failure investigation provides a solid foundation for effective corrective actions and sustainable preventive actions. During this event our presenters will discuss and provide guidelines for establishing and implementing a pragmatic approach to performing root cause analyses and supporting investigations.
Participants will learn how to:
Perform effective investigations, establish the insight needed to yield sustainable improvement, and deliver compliant CAPA documentation.
Speakers: Wade Speir
Wade Speir, Principal Consultant PA Consulting Group Hein Smit Sibinga, Compliance and Risk-Management expert PA Consulting Group - Life Sciences & Healthcare practice
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