Quality Risk Management in Practice

Summary

Quality Risk Management is a core discipline in regulated Life Science environments. It supports better decisions, stronger validation strategies, improved control of computerised systems, and safer implementation of new technologies, including AI.

This course gives you a practical introduction to Quality Risk Management in Life Science, with a focus on pharmaceutical, medical devices, and combination product environments.

The course is based on the principles of ICH Q9 for pharmaceutical quality risk management and ISO 14971 for medical device risk management. The course also links these principles to process validation, GAMP 5, computerised systems validation, and AI governance in regulated environments.

The course gives you a common understanding of key risk concepts, including hazard, harm, hazardous situation, severity, probability, detectability, risk control, residual risk, benefit-risk considerations, and risk acceptance.

You’ll be introduced to commonly used risk tools, including FMEA, Process FMEA, Bow Tie, risk ranking, risk registers, and simple risk-based decision models. The focus is on selecting the right tool for the right situation and avoiding risk management becoming a documentation exercise without real value.

A central theme throughout the course is how risk management can be used in practice to support validation strategy, control strategy, supplier control, deviation handling, change control, CAPA, computerised systems validation, and AI implementation.

The course is based on short presentations, practical examples, group discussions, and exercises based on realistic Life Science cases.

Keywords

• Quality risk management
• ICH Q9 and ISO 14971
• Deviation handling
• CAPA
• Validation