Dublin, April 18, 2024 (GLOBE NEWSWIRE) -- The "ICH Q9(R1) Quality Risk Management (QRM) Training Course" conference has been added to ResearchAndMarkets.com's offering.
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.
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:
- Manufacturing, production management, and technical support functions
- Development scientists
- Engineers
- Regulatory departments
- Quality Assurance
- Supporting companies such as equipment suppliers and consultants
Key Topics Covered:
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
Speakers:
Bruce Davis
Associate
NSF Healthsciences
Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Quality Risk Management, GMP for Engineers and other related topics. He has run many training events for companies both in the UK and internationally and is often invited to speak at international conferences.
He is past Chair of ISPE International Board of Directors and led their case study for practical implementation of QbD. He co-chaired the team updating their Technology Transfer (TT) Guide and carries out training for them and other organisations.
He is a professional engineer and has many years' experience in the pharmaceutical industry and a wide international knowledge, and understanding of current regulatory approaches in the above topics for both US and EU.
He previously worked at AstraZeneca, where he had a number of responsibilities, including managing international engineering, facilitating QbD and leading changes to qualification practices.
He played a leadership role to set up De Montfort University's MSc distance learning course in QbD.
He is an Associate to NSF Healthsciences, and for them has carried out consultancy and training in the above topic areas, and also for driving down human error.
For more information about this conference visit https://www.researchandmarkets.com/r/hqraqf
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