Quality Risk Management Training

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)

In our virtual learning option, training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. 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:

Rachel Carmichael - Rachel is a former UK MHRA GMP Inspector. She has extensive knowledge of pharmaceutical law and its practical implementation.

Peter Gough - Peter has nearly 45 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.

Lynne Byers - Lynne has over 35 years of experience in pharmaceutical manufacturing management and quality assurance, working for three major international pharmaceutical manufacturers. She is an expert in international QA auditing of a wide range of manufacturers supplying the pharmaceutical industry worldwide and has experience managing QA teams’ in-country affiliates.

Lynne has broad experience with a wide range of sterile and non-sterile dosage forms. She is fully conversant with current EU and FDA GMP regulations and requirements.