Quality risk management - how to apply ICH Q9 in practice

1 Day/s

CPD Hours: 7

Classroom, in-house, e-Learning

This one-day course provides the delegate with understanding of the principles of and practical application of Quality Risk Management (QRM).

The course relates to the latest ICH Q9R1 update (18 Jan 2023) and the implications arising from this update. It refers to the use of QRM in development, manufacturing, engineering, validation or other functions. It also covers its links to ICH Q8 (Pharmaceutical Development), Q10 (Quality Systems) Q11 (Drug Substance Development), and ICH Q12 (Lifecycle).

The course is aligned to the latest science and risk-based principles and regulatory guidance in the EU and US. It will go into detail on the steps involved in carrying out a risk exercise, from the initiation stage to completion and review.

Classroom courses - please note, the advertised venue may need to be changed, if the required number of delegates is not met. In this situation, the course will be converted to an Online Virtual course and all delegates notified accordingly. The decision regarding the venue will be made at least 4 weeks before the course is due to run.

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This course is suitable for people in development, manufacturing, engineering or validation who may have no, or limited quality risk management experience or for those with experience but who wish to be updated with the latest application.

This course will cover the following and include presentations and exercises:

  • Regulatory background – EU, US, ICH and elsewhere
  • ICH Q9R1 – the latest amendments and their significance, plus principles and risk tools
  • ICH Q8/11 – product and process understanding
  • Setting up and running an FMEA
  • Exercise - your action plan

    By the end of the course you will be able to:

    • Appreciate the regulatory drivers for QRM, with particular emphasis on European and US requirements
    • Learn about the latest changes and implications of ICH Q9R1 update
    • Understand how ICH Q9R1 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation
    • Appreciate the principles of QRM, the ICH Q9R1 framework and the importance of common language and approaches, including the differences between risk management and risk analysis
    • Recognise the importance of product Critical Quality Attributes, Critical Process Parameters and Control Strategy in regard to science and risk based principles
    • Understand how to set up and run a risk management exercise, including initiation, risk assessment, analysis, control, review and communication
    • Appreciate how to use various risk methodologies, including FMEA, risk ranking, cause effect matrix and other related techniques, such as process flow diagrams, ‘fishbone’, ‘brainstorming’ etc.
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We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

Meet the tutors

Bruce Davis

Bruce Davis carries out training and consultancy in a number of science and risk-based topic areassuch as Quality Risk Management (QRM); Quality by Design (QbD); Process validation/ qualification; Technology transfer. He is an experienced trainer with many years’ experience of the pharmaceutical industry. He tries to ensure participants have an engaging and learning training experience. He has always been interested in the importance of having a patient and science and risk-based approach and in its application during training. He runs his own consultancy business and has done for the past 11 years. He formerly worked at AstraZeneca, where he had an international engineering role, being responsible for putting in place new manufacturing and development facilities. He is past chair of ISPE and has contributed to or colead a number of their industry guides, including Technology Transfer, Process Validation, and a chapter on ATMPs.

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