Presented by
Management Forum
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.
- Format: Live online
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 Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
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
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
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.
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
31 January 2024
Live online
13:30-17:00 UK (London) (UTC+00)
14:30-18:00 Paris (UTC+01)
08:30-12:00 New York (UTC-05)
Course code 14275
- GBP 299 349
- EUR 439 509
- USD 501 579
Until 27 Dec
- 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
Not ready to book yet?
for 7 days, no obligation
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 299 349
- EUR 439 509
- USD 501 579
Until 27 Mar
- 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
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
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.
