ICH Q9(R1) Quality Risk Management (QRM) Training Course

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.

1 May 2024
+ 25 September 2024 »
from £299

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Overview

ICH Q9R1 Quality Risk Management has recently been updated by the regulators.

This update has been triggered by regulators seeing evidence of inadequacies in quality risk management processes, such as unjustified assumptions, unsystematic approaches, formality not commensurate to the risk, high levels of subjectivity, and that these can impact product availability.

This training course will bring participants right up-to-date with the latest Q9R1 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.

This is an ideal opportunity to get up to speed with the recent changes and discuss the implications with an expert in this field.

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

Enrol or reserve

The ICH Q9(R1) Quality Risk Management (QRM) course will cover:

Welcome and Introduction
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 Formaility, Risk-Based Deciision-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 Risks may Change Across the Product Lifecycle with Examples
Q&A and Key Take-Aways

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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.

More details

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

1 May 2024

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14276

GBP 349
EUR 509
USD 579

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

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Not ready to book yet?

for 7 days, no obligation

25 September 2024

Live online

13:30-17:00 UK (London) (UTC+01)
14:30-18:00 Paris (UTC+02)
08:30-12:00 New York (UTC-04)
Course code 14277

GBP 299 349
EUR 439 509
USD 501 579

Until 21 Aug

3 hours of live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.