Corrective and Preventive Actions CAPA Management using root cause analysis tools like 5 why, fishbone diagram and FTA.
What you will learn
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Understanding CAPA Fundamentals β Learn the key principles, regulatory expectations, and industry best practices for CAPA implementation.
Root Cause Analysis Techniques β Master proven methodologies like 5 Whys, Fishbone Diagram, and FMEA to identify and eliminate root causes.
CAPA Investigation & Documentation β Develop a structured approach to document, investigate, and verify CAPA effectiveness.
Regulatory Compliance & Audit Readiness β Align CAPA processes with FDA, WHO, EU GMP, and ICH Q10 requirements to ensure compliance.
Risk-Based CAPA Implementation β Learn how to prioritize CAPA actions using risk management principles and data-driven decision-making.
Preventive Action Strategies β Go beyond corrective actions by proactively identifying potential failures and implementing long-term preventive measures.
Measuring CAPA Effectiveness β Track CAPA performance using key metrics and trend analysis for continuous improvement.
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