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

Aneta Jell
Paul R Palmer

Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience
across manufacturing, contract operations, and quality leadership in the pharmaceutical
industry. Currently serving as Quality and training manager at PaulPalmer limited she
oversees global contract manufacturing quality, ensuring GxP compliance, regulatory
alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and
QMS administration, with proven strength in audits, CAPA, deviations, and technical
agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak,
Aneta is recognised for driving continuous improvement, fostering compliance culture, and
leading high-performing quality and HSE teams.

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Farah Nadeem
Paul R. Palmer Limited

Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.

Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.

In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.

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