ICH Q9(R1) Quality Risk Management (QRM) In-house Training

An Essential Update

ICH Q9(R1) Quality Risk Management has recently been updated by the regulators. This training course will bring participants right up-to-date with the latest Q9(R1) requirements. It will explain the changes and give context as to how these impact pharmaceutical products and processes. It will cover a range of product types and situations.

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ICH Q9(R1) Quality Risk Management (QRM)

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Course overview

Stay updated on the recent revisions to ICH Q9R1 Quality Risk Management by regulators and gain insights into its practical application in pharmaceutical manufacturing.

This training is crucial to understand the revisions made in response to regulatory observations of inadequacies in quality risk management processes, which have shown unjustified assumptions, unsystematic approaches, inadequate formality relative to risk, subjective evaluations, and potential impacts on product availability

Participants will be brought up-to-date with the latest requirements of Q9R1, understanding its changes and their implications for pharmaceutical products and processes across various situations and product types.

Engaging with experts in the field provides an ideal platform to grasp these recent updates comprehensively and discuss their practical implications.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines. For more information on the latest EU GMP regulations, see our GMP training course covering the Annex 1.

Benefits of attending

Keep up to date with the changes
Understand the implications on products and processes
Discuss new terms such as subjectivity, uncertainty, importance and complexity
Stay abreast of the latest thinking on Quality Risk Management (QRM)

Who should attend?

Anyone from the pharmaceutical industry or related academia who wants to ensure they are up-to-date with the latest thinking on QRM, including:

Manufacturing, production management, and technical support functions
Development scientists
Engineers
Regulatory departments
Quality Assurance
Supporting companies such as equipment suppliers and consultants

This course will cover:

Background to Q9(R1) regulatory update
Summary of the main steps for a QRM approach from 'Initiation to Review'
Explanation of the main changes and how this will impact development and manufacturing processes
Introduction of new terms such as formality, risk-based decision-making, subjectivity, and what they mean
Examples of good and poor practices in the use of QRM for a range of pharmaceuticals
The importance of QRM and product availability risks
How risk may change across the product lifecycle with examples

Bruce Davis
Bruce Davis Ltd

Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality Risk Management and other related topics. He has run many training events for companies both in the UK and internationally. He is past Chair of ISPE International Board of Directors. He led, co-lead or contributed to a number of their guidances for PV, QbD & TT and most recently has co-written one chapter on TT for ATMPs (i.e personalised medicines) . He is a professional engineer with many years’ experience in the pharmaceutical industry and a wide international knowledge. He previously worked at AstraZeneca, where his responsibilities included managing international engineering and leading changes to qualification practices. He is an established trainer and likes to engage with participants, to try to ensure the training experience is related to their particular requirements, and to bring in the importance of science and risk based thinking.

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