Corrective & Preventive Action (CAPA) Management Training Course

Course Overview

Learning Objectives

• Analyse the purpose, principles, and structure of an effective CAPA management system.
• Identify events and quality signals that require corrective or preventive action.
• Evaluate problems and risks to determine appropriate CAPA priorities.
• Develop clear problem statements supported by objective evidence.
• Apply structured root cause analysis to identify underlying causes.
• Distinguish immediate corrections, corrective actions, and preventive actions.
• Develop risk-based corrective and preventive action plans.
• Establish clear responsibilities, timelines, and implementation controls.
• Evaluate the adequacy and effectiveness of proposed CAPA actions.
• Design effective methods for verifying action effectiveness and preventing recurrence.
• Develop CAPA documentation, reporting, monitoring, and escalation mechanisms.
• Integrate CAPA with audits, nonconformities, risk management, quality systems, and continuous improvement.

Who Should Attend

Learning Outcomes

• Explain the role and structure of CAPA within an effective quality management system.
• Identify quality events and performance signals that may require CAPA.
• Assess issues according to severity, risk, impact, and recurrence potential.
• Develop precise and evidence-based problem statements.
• Conduct structured investigations to determine root causes.
• Distinguish between correction, corrective action, and preventive action.
• Develop practical actions that address verified root causes.
• Establish appropriate ownership, timelines, priorities, and implementation controls.
• Evaluate proposed actions before implementation.
• Verify the effectiveness and sustainability of completed CAPA actions.
• Identify systemic issues and opportunities for broader preventive improvement.
• Develop CAPA performance measures and integrate CAPA findings into continuous improvement.

Course Outline