Quality Risk Management Training
About This Course
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.
Why You Should Attend
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.
Key Learning Objectives
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
Course Outline
- 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
Who Should Attend
- 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
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.
Excellent insight into problem-solving and assessing risk. Buzz groups challenging, backing up the theory. Great learning environment.
Supplier Quality Management
The Role and Professional Duties of the Qualified Person
Equipment Qualification and Process Validation
Additional Recommended Courses
Responsible Person and Good Distribution Practice (Cogent Gold Standard Approved Training)
An interactive good distribution practice (GDP) and responsible person training course, focusing on the key requirements for the distribution and storage of pharmaceutical products and materials, which will enable delegates to understand and effectively implement the principles of GDP at their facilities.
This Cogent-approved course will be presented virtually through a combination of self-paced learning hosted on our Learning Management System and four half-day virtual classroom sessions. Full details, including timings for the instructor-led virtual classrooms, will be emailed following registration.
Tutor: Samantha Clack
Price: £1980 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities and NHS staff are entitled to a 20% discount. (Proof will be required).
Quality Risk Management
A highly interactive course designed to provide you with the tools and techniques to improve your decision-making skills and better protect your company and the patient. This course addresses both proactive and reactive risk management. We will show you how to take a structured, risk-based approach to problem-solving and decision-making, using techniques such as failure mode effect analysis (FMEA), hazard analysis critical control point (HACCP), 5 whys and fishbone diagrams. You will practice resolving real-life scenarios and case studies using these tools to great effect. In short, we will provide you with the skills and tools to turn data into information and improve decision-making at work!
Tutor: Rachel Carmichael
Price: £780 excluding VAT (where applicable)
Please note: payment by credit/debit card will be required at time of booking.
You can view our booking terms and conditions from here.
Pharmaceutical Quality Systems
In this intensive, highly interactive four-day course you will learn the essential elements of an effective, compliant, modern pharmaceutical quality system and how to implement, monitor and manage a system to meet the needs of all the major international regulatory agencies.
Learn how to simplify systems and add value to your company, not just cost!
Tutors: Samantha Clack, Vicky Baulch
Price: £3160 excluding VAT (where applicable)
Course registrations will close 5 working days before the start of the course.
You can view our booking terms and conditions from here.
Multiple Delegate Discounts are available for delegates from the same company attending the same course.
The first delegate must pay full price. The second delegate will receive a 20% discount. The third and any subsequent delegates will receive a 50% discount. Charities, NHS staff are entitled to a 50% discount. (Proof will be required).