Root Cause Analysis of Failures & Deviations - Developing an Effective CAPA Strategy
October 1 - 3, 2014 - Malvern PA USCenter for Professional Innovation and Education, Inc.
info@cfpie.com
Phone:(610) 688-1708
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. Additional benefits of this class include: •Learn not just from the Director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their challenges, problems, and issues for classroom discussion. Ample time is provided to address specific problems and questions of individual participants •Explore the use of brainstorming, process mapping and regulatory resources •Participants will also have the opportunity for one-on-one consultation with the Course Director during course breaks and in the evenings This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.