Corrective & Preventive Action (CAPA)

This hands-on course covers:
• Regulatory CAPA requirements (ISO, FDA, GMP, ICH, GHTF)
• Advanced root cause analysis for complex, multi-causal problems
• Risk assessment tools (FMEA, FTA, statistical analysis)
• Developing SMART corrective action plans that prevent recurrence
• Measuring CAPA effectiveness through data-driven verification

Who Should Attend? 
This course is essential for professionals responsible for quality, compliance, and continuous improvement in regulated industries, including:

Learning Objectives:
• Quality Managers & Compliance Officers
• Regulatory Affairs Professionals
• Operations Directors & Process Engineers
• Pharmacists & Healthcare Practitioners
• Safety Officers & Risk Management Specialists
• Auditors & Continuous Improvement Leaders

Key Learning Outcomes
• Explain the key CAPA requirements under ISO 13485, FDA 21 CFR Part 820, and EU MDR/IVDR and how they apply to non-conformances, corrections, corrective actions, and preventive actions.
• Detect quality issues through customer complaints, audits, and inspections, and evaluate their significance using risk assessment tools (e.g., FMEA, severity-frequency-detection analysis).
• Utilize structured problem-solving techniques such as 5 Whys, Fishbone Diagrams, Pareto Analysis, and Brainstorming to determine underlying causes of non-conformances.
• Formulate SMART (Specific, Measurable, Achievable, Relevant, Time-bound) corrective and preventive actions through collaborative decision-making to eliminate root causes and prevent recurrence.
• Monitor and validate the success of implemented actions through follow-up audits, control charts, and performance metrics, ensuring sustained compliance with regulatory standards

Why Choose This CAPA Training?
✅ Regulatory-Focused – Meets strict ISO, FDA, and GMP compliance requirements
✅ Practical & Tool-Based – Hands-on exercises with FMEA, FTA, and statistical analysis
✅ Risk-Driven Approach – Prioritises actions based on impact and probability
✅ Proven Framework – Ensures sustainable fixes, not just temporary patches