Corrective Action and Preventive Action (CAPA) Training

Corrective Action and Preventive Action (CAPA) is a core FDA GMP requirement used to investigate nonconformities, identify root causes, and prevent issues from recurring in pharmaceutical and medical‑device operations. This course provides a practical introduction to CAPA principles under FDA 21 CFR 820.100, using real‑world examples to show why effective CAPA is essential.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.
 
Who should enroll?

• Quality Assurance and Quality Control professionals
• Manufacturing and operations teams
• Regulatory Affairs specialists
• GMP compliance and audit personnel
• Pharmaceutical and medical‑device supervisors or managers

 
What you’ll learn?

• Understand CAPA principles and their role in FDA‑regulated GMP environments
• Distinguish between corrective actions and preventive actions
• Conduct structured investigations and root‑cause analysis
• Execute the CAPA process from identification through verification and closure
• Document CAPA activities using compliant templates and forms

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

Final assesment