Quality Risk Management Fundamentals

Quality Risk Management (QRM) has become a key element across the life science industry. Regulatory authorities such as EMA and DKMA now expect risk management to be integrated into all major decisions – from product development and process design to batch release and continuous improvement.

This course gives you a fundamental understanding of the principles behind QRM and shows you how to apply its methods in your own organisation. The training is based on the ICH Q9 guideline and its practical relevance to GMP activities. You will gain insight into both the classical and the modern approaches to risk management.

Through case work, you will get hands-on experience with risk assessment and learn how to select the right level of formality – from structured models such as FMECA to more informal approaches used in everyday decision-making.

We focus on the basic concepts and traditional methods, and build on the modern understanding of QRM with special emphasis on the revised ICH Q9 and the latest expectations from the authorities – including a presentation from the Danish Medicines Agency (DKMA).

Throughout the course, there will be plenty of opportunities to exchange experiences and discuss practical challenges with other participants.

The course provides a solid understanding of how QRM supports the pharmaceutical quality system and helps you prioritise resources where the risks are highest.

The course language is English.
If all participants are Danish-speaking, the course will be conducted in Danish with English slides.