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. Strong CAPA systems protect product quality, ensure regulatory compliance, and support a culture of continuous improvement.

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.

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.

🚀 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