Learning Outcomes

In this free course, you will learn how to:

• Define corrective and preventive action within the context of quality management systems
• Explain the regulatory requirements for CAPA in industries such as pharmaceuticals, food and biotechnology
• Compare corrective action and preventive action, highlighting their distinct roles
• Generate effective corrective action and preventive action plans with clear timelines and responsibilities
• Identify common triggers for CAPA, including deviations, audits, and customer complaints
• Apply root cause analysis tools such as the 5 Whys and fishbone diagrams to CAPA investigations
• Illustrate best practices in CAPA documentation and reporting for regulatory compliance
• Evaluate CAPA effectiveness using defined criteria, verification steps, and performance metrics
• Analyse case studies from the pharmaceutical and food industries to understand real-world CAPA applications
• Match CAPA processes to organisational quality systems to promote continuous improvement