- Live online
- In-house
- 6 CPD hours
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. More details...
Questions?
Contact Harry about this course, or call us on +44 7749 4749
Live online
- 09:00 - 17:00 UK (London) (UTC+00)
- 10:00 - 18:00 Paris (UTC+01)
- 04:00 - 12:00 New York (UTC-05)
Course code 16902
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Live online
- 09:00 - 17:00 UK (London) (UTC+01)
- 10:00 - 18:00 Paris (UTC+02)
- 04:00 - 12:00 New York (UTC-04)
Course code 17261
3rd place FREE
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Live online
- 09:00 - 17:00 UK (London) (UTC+00)
- 10:00 - 18:00 Paris (UTC+01)
- 04:00 - 12:00 New York (UTC-05)
Course code 17557
3rd place FREE
£649 / €909 / $1,043
Pricing details: multiple places, early booking discounts
Tailored to your team's requirements, at your choice of location or online.
From
£350
Per delegate, based on 10 delegates and a duration of 2 days
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
4 Dec 2026
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.
24 Jun 2027
3 Dec 2027
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.
4 Dec 2026
24 Jun 2027
3 Dec 2027
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.
United Kingdom
- Advanced healthcare ltd
- Advanced Healthcare Ltd Unit 2-4
- Hoeford Research Ltd
Ireland
- Gilead Sciences
Malta
- Baxter Healthcare Corp
Run ICH Q9(R1) Quality Risk Management (QRM) Live online for your team
Half-day
Typical duration
Pricing from:
- GBP 350
- Per attendee, based on 10 attendees
- Course tailored to your requirements
- At your choice of location, or online
We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our team to discuss your requirements:
