Course overview
This full‑day masterclass goes beyond the fundamentals of ICH Q9(R1) and focuses on how to operationalise the revised guideline in real‑world GMP environments. Participants will learn how to transform QRM from a compliance activity into a strategic, data‑driven decision‑making framework that strengthens product availability, contamination control, and organisational resilience.
The course blends practical exercises, scenario‑based workshops, and interactive simulations to help teams apply the new principles of subjectivity reduction, uncertainty management, proportionality, and lifecycle‑integrated risk thinking.
This programme is ideal for organisations seeking to modernise their QRM systems, align with evolving regulatory expectations, and prepare for the digital future of risk management.
CPD Hours: 6
Course Content
- Day 1
- Module 1: The new QRM landscape
- Module 2: Bias, uncertainty & decision quality
- Module 3: Advanced hazard identification
- Module 4: Proportionality & right sizing
- Module 5: Digital QRM & AI enabled risk systems
- Module 6: Building a future ready QRM programme
- Case Study - Risk scoring & risk based decision making
Speakers
Paul Palmer
Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development, manufacture and supply of medicinal products and medical devices.
Throughout his career, Paul has intentionally taken on all opportunities as they arose in order to develop a broad range of knowledge with an in-depth detailed understanding of manufacturing, storage, distribution, research, computerised systems, as well as the facilities and services to support each.
People and systems have always been a core focus, how to ensure best use, optimise and enhance efficiency. He has a level of curiosity rarely displayed in people taking on the qualified person role in pharmaceutical manufacturing. Culture, behaviour and psychology are all significant influences on the systems and processes we implement, but are often ignored.
Paul studied psychology as part of his MSc in 1993 and has always enjoyed observing the world around him with a curiosity that is rarely satisfied.
