Corrective and Preventive Actions CAPA Administration utilizing root trigger evaluation instruments like 5 why, fishbone diagram and FTA.
What you’ll be taught
Understanding CAPA Fundamentals – Study the important thing ideas, regulatory expectations, and trade greatest practices for CAPA implementation.
Root Trigger Evaluation Strategies – Grasp confirmed methodologies like 5 Whys, Fishbone Diagram, and FMEA to determine and get rid of root causes.
CAPA Investigation & Documentation – Develop a structured method to doc, examine, and confirm CAPA effectiveness.
Regulatory Compliance & Audit Readiness – Align CAPA processes with FDA, WHO, EU GMP, and ICH Q10 necessities to make sure compliance.
Danger-Based mostly CAPA Implementation – Discover ways to prioritize CAPA actions utilizing threat administration ideas and data-driven decision-making.
Preventive Motion Methods – Transcend corrective actions by proactively figuring out potential failures and implementing long-term preventive measures.
Measuring CAPA Effectiveness – Monitor CAPA efficiency utilizing key metrics and pattern evaluation for steady enchancment.
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