Quality Risk Management Training

Updated to reflect the 2023 Revision 1 of ICH Q9, this interactive training course provides you with a thorough understanding of quality risk management as set out in ICH Q9. We explore the full extent of the approach and practice the most commonly used tools and techniques to improve your decision-making skills, and better protect your company and your patients by addressing both proactive and reactive risk management.

We show you how to take a structured, risk-based approach to quality management to enable a science- and data-based approach toward the business, enabling a detailed process understanding to allow establishing control strategies. We explore the best practice approaches including risk perspectives and incorporating risk in the pharmaceutical quality system.

We start with underlying facilitation methods and tools such as flowcharts, process mapping, and cause and effect diagrams (also called Ishikawa or fish bone diagrams). We then consider the statistical tools that enable effective data assessment, aid in determining the significance of the data set(s) and facilitate more reliable decision-making, including control charts to turn data into information.

We introduce the less frequently used tools and their applicability, and explore real-life scenarios and case studies using the most commonly used techniques of failure mode effect analysis (FMEA) and Hazard Analysis and Critical Control Point (HACCP)

Our virtual instructor-led training will be delivered through live instructor-led virtual classrooms. Full details will be sent to you following registration.

ICH Q9 is essential for our Industry. Managers with responsibility for managing risk should attend this course to ensure they are equipped to assess a variety of risks and make decisions on priorities and mitigating actions. The course helps participants realize it is not possible to do everything. It will also provide the tools to help make the right decisions to ensure resources are spent on the most important activities. These tools can then be utilized directly in participants’ own companies.

By the end of this training, you will:

• Understand how to apply ICH Q9 routinely and in times of crisis in the workplace
• Learn how and when to use the supporting facilitation and statistical tools
• Learn decision-making tools such as FMEA and HACCP

• Risk-based decision-making – the theory
• Practical implementation and use of ICH Q9
• Good decision-making practices (reactive and proactive)
• FMEA and HACCP
• Fishbone diagrams and many more techniques

• Managers responsible for managing risk across a wide range of functions such as procurement, manufacturing and quality
• Professionals who wish to improve their decision-making skills

Course tutors will be selected from the following:

Kay Hukin - Kay is a PhD microbiologist, a member of the Royal Society of Biology, and eligible to act as a Qualified Person under the permanent provisions. She has over 20 years of experience in pharmaceutical quality across manufacturing, packaging, and testing for commercial and investigational medicinal products. Before joining NSF in August 2024, she served as Quality Director at a contract development and manufacturing organisation. Her background spans QC, QA, and manufacturing for oral solid dose, oral liquids, and sterile products for both commercial supply and early-phase or clinical trial use. She has extensive experience in manufacturing, packaging and labelling, facilities and systems implementation, technology transfer, outsourcing as both contract giver and acceptor, and importation across the EU and third countries. She also brings strong expertise in compliance and efficiency improvements to enhance right-first-time performance and reduce cost of quality. Kay is an experienced international QA auditor of manufacturers, suppliers, and distribution hubs in the UK, Europe, and India. Her areas of expertise include solid, liquid and sterile manufacturing operations, early-phase development and IMPs, quality management systems, microbiology laboratory controls, supply chain and vendor management, regulatory compliance, and QP development, training and mentoring.

Peter Gough - Peter has 50 years' pharmaceutical industry experience, with over 20 years as a practicing QP. He is also a former chair of the Royal Society of Chemistry’s QP Assessor Panel and was one of the original participants in the writing of ICH Q9.