GXP2146 Corrective Action and Preventive Action (CAPA) Course

Potential and actual problems in production runs need to be treated at a foundational level to limit occurrences and reoccurrences. This is why GMP is the standard for manufacturing in the pharmaceutical and allied industries. Corrective Action and Preventive Action (CAPA) is one of the tools for maintaining the quality of the final product. This concept includes the identification of nonconformity or potential nonconformity in product batches and leads ultimately to the resolution of these issues at the ground level following detailed analysis and planning. This course introduces participants to CAPA and regulations that guide it (FDA 21 CFR 820.100.)

In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice.

Curriculum

Introduction

Lesson 1: What is CAPA?

• Differences and Relationship Between Corrective and Preventive Action

Lesson 2: Purpose of CAPA

Lesson 3: CAPA Requirements

Lesson 4: CAPA Procedures

• Identification of the Nonconformity
• Evaluation of the Nonconformity
• Investigation and Root Cause Analysis
• Action Plans
• Implementation of Action Plan
• Verification
• Closure

Lesson 5: Objectives of CAPA

Lesson 6: Filling The CAPA Template Form

Glossary

Conclusion

Quiz