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.
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)
Certifications:
- CPD: 3 hours for your records
- Certificate of completion
Agenda
- 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
Speakers
Mr Bruce Davis,
Associate ,
NSF HealthsciencesBruce 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.
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
