Quality Risk Management - How to Apply ICH Q9 In Practice

Thorough QRM Training with Latest ICH Updates and Practical Applications

Quality Risk Management (QRM) is a requirement of the pharmaceutical industry and concerns the process of identifying, evaluating and mitigating risks connected with development and manufacture of medicines and other related products. An effective and robust QRM programme reduces risk to a manageable level and helps to ensure the delivery of quality products to patients.  

 

This highly interactive, one-day training course provides you with a thorough understanding of quality risk management, covering the latest ICH Q9R1 update (18 Jan 2023) and the implications arising from it.  

 

This training is aligned to the latest science and risk-based principles, taking into account regulatory guidances in both the EU and US). It covers the use of QRM in development, manufacturing, engineering, validation and other functions. This training includes reference to ICH Q8 (Pharmaceutical Development), Q10 (Quality Systems) Q11 (Drug Substance Development), and ICH Q12 (Lifecycle). 

 

Interested in quality risk management training for your team? Contact us today. 

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Duration
1 day
CPD Hours
7 hrs
Locations
  • Reading (RSSL)

Who Should Attend

This course is suitable for those involved in development, manufacturing, engineering or validation who may have no, or limited QRM experience, or wish to update their knowledge regarding the latest developments. 

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Key topics

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

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    The regulatory background – EU, US, ICH and elsewhere 

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    ICH Q9R1 – the latest amendments and their significance, plus principles and risk tools 

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    ICH Q8/11 – product and process understanding 

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    Setting up and running an FMEA 

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    Creating your action plan (learning exercise) 

Learning Outcomes

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

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    Appreciate the regulatory drivers for QRM, with particular emphasis on European and US requirements 

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    Understand the latest changes and implications of ICH Q9R1 update 

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    Understand how ICH Q9R1 underpins ICH Q8, Q10 and Q11 for activities in development, manufacturing, engineering and process validation 

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    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 

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    Recognise the importance of product critical quality attributes, critical process parameters and control strategy in regard to science and risk-based principles 

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    Understand how to set up and run a risk management exercise, including initiation, risk assessment, analysis, control, review and communication 

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    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. 

Meet your expert tutors

Learn from the best in the industry. Our diverse team of highly experienced subject matter experts are passionate about sharing their knowledge with you. 

Bruce Davis (2)

Bruce Davis

An experienced tutor, Bruce understands the importance of engaged, active learning. Focusing on patient safety, Bruce ensures his sessions have a solid scientific approach, providing practical insights and real-world application. Having run his own consultancy for 15 years, Bruce specialises in risk-based topic areas including Quality Risk Management, Quality by Design, process validation / qualification and technology transfer.
Frequently asked questions

If you have any questions about this course we have answered some of the most common ones below. If you still aren't finding what you're looking for you can contact our team here.

What our clients say

Discover the feedback from our course alumni and learn why they chose RSSL to support their professional development. 

Very good

A good introduction to ICH Q9
Anonymous
PCI Pharma Services

Useful

Insightful and valuable.
Anonymous
Pharmaron UK Ltd

Book Your Place

Quality Risk Management - How to Apply ICH Q9 In Practice
19 Nov 2025
-
Reading (RSSL)
£590 excl VAT
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Bespoke Training

We offer bespoke in-house training solutions to you and your organisation. Contact an expert today to talk about your team and your specific requirements.

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Special Offers

We offer a number of discounts and specials offers on our training courses including Group booking, NHS and Seasonal discounts.

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Why choose RSSL?

As scientists ourselves, we’re passionate about collaboration and sharing our expertise to nurture the next generation. By helping them to develop and fulfil their potential, we can tackle 21st-century pharmaceutical scientific challenges more effectively.

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    More than 30 years of experience upskilling pharmaceutical professionals

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    Small-group training adjusted to individual learning styles and needs

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    50+ training courses accredited by recognised industry bodies

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    Combination of off-the-shelf and bespoke training packages

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    Courses and consulting led by experts in the entire pharmaceutical life cycle

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    Opportunity to share and learn as part of a diverse community