This course is intended to provide students with the elements of a corrective and preventive action (CAPA) system, taken to eliminate causes of non-conformities or other undesirable situations.

This course is broken down into three modules. The first module identifies the primary elements and sequence of activities for conducting a CAPA. The second module explains how to define a problem statement and conduct the root cause investigations, tools that can help you in effectively investigating problems. The third module explains how to implement and effectively close out a CAPA.

At The End Of The Course You Will Be Able To

• Understand FDA’s and other regulatory officials’ expectations for “what CAPA is” and the steps required to get you there.
• Know how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.
• Understand the main elements and sequence of activities for conducting a CAPA.
• Understand how to define a problem statement, the conducting of root cause investigations, tools that can aid you in effectively investigating problems.
• Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.
•  Understand how to establish a compliant Corrective Action and Preventive Action (CAPA).

Course Content

1.  Module 1. Initiate – Investigation Plan – Correction/Containment
   • Introduction to CAPA
   • Initiation
   • Investigation
   • Plan
   • Containment / Correction
2. Module 2. Investigation, Root Cause Analysis – Solution V&V
   • Root Cause Analysis
   • Solution V&&
3. Module 3. Implementation-VoE-Closure
   • Implementation
   • VoE
   • Closure