Master Regulatory-Compliant CAPA Systems Using Advanced Risk Management Tools
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Our Corrective and Preventive Action (CAPA) Training provides professionals with a structured, risk-based methodology to effectively identify, analyze, and resolve quality and compliance issues in regulated environments.
This hands-on course covers:
This course is essential for professionals responsible for quality, compliance, and continuous improvement in regulated industries, including:
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.
Meets strict ISO, FDA, and GMP compliance requirements.
Hands-on exercises with FMEA, FTA, and statistical analysis.
Prioritises actions based on impact and probability.
Ensures sustainable fixes, not just temporary patches.
Equip your team with the skills and tools to solve problems at the root and prevent them from happening again.