Learning Outcomes

In this free course, you will learn how to:

• Define the principles of deviation management, change control, and Quality Management Systems
• Describe the processes involved in reporting, investigating, documenting, and closing deviations
• Distinguish between planned and unplanned deviations, as well as minor, major, and critical deviations
• Explain the stages of the change control lifecycle, including risk assessment, impact assessment, approval, etc
• Analyse the causes of deviations using structured root cause analysis techniques
• Evaluate the effectiveness of Corrective and Preventive Actions (CAPA) and change control activities
• Assess the regulatory expectations of GMP, FDA, WHO, PIC/S, and ISO
• Illustrate the application of deviation handling and change control principles through practical industry case studies
• Compare common weaknesses and best practices in quality systems to support continuous improvement
• Summarise the key elements required to build and maintain an effective Quality Management System