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Corrective and Preventive Action and Effective Root Cause Analysis

This course teaches participants an effective Root Cause Analysis process and the requirements, strategies, and best demonstrated practices for a compliant Corrective and Preventive Action system.

Participants will learn the regulatory requirements for Corrective and Preventive Action (CAPA) and how to structure their system to meet these requirements. Participants will also learn an eight-step process for performing Root Cause Analysis. Each step of the process will be explained in detail using an interactive approach and an interesting case study. Each lesson is reinforced using learning games and/or quizzes. There is a final test. Throughout the course participants receive tips based on VCI’s years of experience to help participants improve their own CAPA systems.

Who Should Participate:	Supervisors, managers & technicians in Production, Engineering, Quality Control & Assurance, and other personnel, who perform investigations, write or revise investigation reports, or manage CAPA systems.
Class Length:	Normally four hours
Course Prerequisites:	None
Course Objectives:	At the conclusion of the class participants will be able to:

Summarize the regulatory requirements and expectations for CAPA and Root Cause Analysis
Explain the legal and business reasons for developing a compliant CAPA system
Identify pitfalls of having an ineffective CAPA system
Define terms commonly associated with CAPA and Root Cause Analysis such as correction, corrective action, preventive action, and root cause
List the foundations of an effective CAPA system
Explain the difference between fixing the symptom of a problem and correcting the actual root cause
Explain the benefits of conducting an investigation using a systematic approach
List different types of mistake-proofing and explain how they can be used in a CAPA system
Summarize the cGMP requirement for CAPA timeliness
Provide examples of how to verify/validate effectiveness of Corrective and Preventive Actions
Explain what an FDA inspector looks for when investigating a CAPA system