Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy

Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections.  This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis. 

The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations.  Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis.  Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, categorizing problems, assigning responsibility and tracking team activities.