ICH Q9(R1) Quality Risk Management (QRM) In-house Training

An Essential Update

A full-day masterclass that shows GMP teams how to put ICH Q9(R1) into practice. Learn how to turn Quality Risk Management from a compliance exercise into a practical, data-driven approach that strengthens product availability, contamination control, and regulatory readiness.

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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.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Translate ICH Q9(R1) principles into operational QRM frameworks
Build risk systems that support supply continuity and contamination control
Apply proportionality to ensure QRM effort matches true risk impact
Identify and mitigate cognitive bias in risk assessments
Quantify uncertainty and incorporate it into decision making
Use structured techniques to uncover hidden hazards

Who should attend

This course is designed for a cross-functional pharmaceutical audience - anyone involved in making, reviewing, or approving risk-based decisions in GMP operations. Attendees include:

Quality Assurance and Quality Control personnel
Risk owners and decision makers
Manufacturing & operations leaders
Process development & validation specialists
Engineering and Technical Support
Regulatory Affairs professionals
Supply Chain and technical operations managers
Validation, Process Development, and Engineering roles
Regulatory affairs teams
Consultants, Auditors, and Service Providers
Digital transformation and data analytics roles

This course will cover:

Module 1: The new QRM landscape

Why Q9(R1) matters now
Regulatory signals and inspection trends
The shift from compliance to strategic risk management

Module 2: Bias, uncertainty & decision quality

Deep dive into subjectivity drivers
Tools to reduce bias in cross‑functional teams
Practical uncertainty scoring models

Module 3: Advanced hazard identification

Systems thinking approaches
Failure pattern recognition
Hazard identification for contamination control
Simulation: Hidden hazards in a sterile manufacturing scenario

Module 4: Proportionality & right sizing

When to use high formality vs low formality QRM
Scaling tools for product availability risks
Case Study: Choosing the right level of formality

Module 5: Digital QRM & AI enabled risk systems

Data driven risk review
Digital maturity models for QRM
AI use cases in hazard detection and trending
Interactive Exercise: Designing a digital QRM dashboard

Module 6: Building a future ready QRM programme

Integrating QRM across the lifecycle
Strengthening contamination control strategy
Preparing for next generation regulatory expectations
Group discussion & action planning

Case Study - Risk scoring & risk based decision making

Paul Palmer
Paul R Palmer Ltd

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.

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