Guide to Effective CAPA Management

Corrective and Preventive Actions CAPA Management using root cause analysis tools like 5 why, fishbone diagram and FTA.

Created by: Ankur Choudhary
Pharmaceutical Professional Blogger, and Course Creator.

What Will I Learn?

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

Requirements

• No prior CAPA experience is required! Whether you're a beginner or an experienced professional, this course will provide step-by-step guidance to effectively manage CAPA processes.

Target audience

• Quality Assurance (QA) & Quality Control (QC) Professionals – Ensure effective CAPA implementation to improve product quality and regulatory compliance.
• Regulatory Affairs Specialists – Understand CAPA expectations from FDA, WHO, EU GMP, and ICH Q10 to maintain compliance during inspections and audits.
• Manufacturing & Production Personnel – Identify, investigate, and prevent recurring quality issues in pharmaceutical and biotech manufacturing.
• GMP Auditors & Compliance Managers – Strengthen audit readiness and CAPA documentation to meet regulatory expectations.
• R&D and Laboratory Professionals – Learn how CAPA applies to analytical laboratories, method validation, and process development.
• Pharmaceutical & Biotech Industry Professionals – Anyone responsible for ensuring continuous improvement in quality management systems (QMS).