Course description
Quality Risk Management
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)
Suitability - Who 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.
Outcome / Qualification etc.
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
Training Course Content
- 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
Course delivery details
If you choose our virtual learning option, training will be delivered via a combination of an instructor-led virtual classroom and self-paced learning online. Full details will be sent to you following registration.
All of NSF's pharmaceutical training courses can be brought on-site, tailored to your key concerns and delivered at a time that suits you.
Why choose NSF International, Health Sciences
Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course
Provided expert health sciences training for over 30 years
More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider
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Expenses
Discounts
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.