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Pharmaceutical Root Cause Analysis of Failures & Deviations
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Pharmaceutical Root Cause Analysis of Failures & Deviations

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.

6/24/2015 to 6/26/2015
When: June 24-26, 2015
9:00 a.m. - 3:00 p.m.
Where: The Hilton Los Angeles Airport (LAX)
5711 West Century Boulevard
Los Angeles, California  90045
United States
Presenter: The Center for Professional Innovation & Education, Inc.
Contact: Olivia Carlin
610.648.7550

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Pharmaceutical 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.

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

Learn more about the course and register.

CfPIE is a preferred provider and offers MichBio members a 15% discount on course registration fees. Click here for more information.

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