Clinical Quality Management Systems
With increasing clinical quality standards required by inspectors, there is currently no harmonised regulatory guidance for clinical quality management systems (CQMS), although there are multiple documents from different sources across the pharmaceutical and medical device industries. The regulators however, both in Europe and the US, expect an effective QMS to be in place for clinical development. Organisations are struggling to effectively implement and integrate these QMS standards, including ISO 9000 principles, ICH10 for CQMS and ICH R2 CQMS requirements.
This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality. The interactive programme will discuss the proposal for a new industry best practice CQMS framework as well as the new EMA TMF guideline requirements and implications for CQMS.
Benefits of attending:
- Understand developing regulatory requirements for clinical quality management systems (CQMS)
- Review the new proposed CQMS framework
- Consider best practice in key CQMS areas including risk-based elements, CAPA, documentation and new EMA requirements for TMF systems
- Discuss the importance of key performance indicators (KPIs) in your CQMS
Who Will The Course Benefit?
This course is aimed at anyone working in clinical research or associated functions, including regulatory affairs and document management, who needs to know how to establish, maintain, monitor and improve a CQMS that focuses on product quality and compliance to GCP.
The programme will also be of value to those working in quality assurance and quality improvement roles in clinical research, management responsible for governance of CQMS and anyone working with or in clinical research who needs to comply with the new requirements for CQMS, including study sites.
It is ideal for those implementing a CQMS, those wanting to share best practice and anyone wanting an update on new developments in this area.
Programme - Day 1What is clinical quality and CQMS?
- Quality principles and definitions
- The new proposed CQMS framework
- How does the CQMS fit within the organisation’s QMS?
- Regulatory drive for CQMS
- The components of a CQMS
- Quality by design – what does it mean and how does it apply to clinical research and the CQMS?
- What are inspectors looking for?
- Feedback from the regulators – hot inspection topics and trends
- Balancing strict regulations and progress in research
- Documentation of KPIs and key performance tolerance levels
- Implementing quality tolerance limits (QTL) – examples and tips
- Management review and governance of a CQMS
Programme - Day 2Risk-based component of CQMS
- Risk methodologies to include in CQMS
- ICH GCP R2 risk-based elements of a CQMS
- Outsourcing and partnership
- Demonstrating and documenting vendor oversight to inspectors
- Metrics and KPIs
- Correction, corrective action, preventive action and root cause analysis
- Examples of technology solutions and support technologies for CQMS
Provider: Management Forum
Management Forum - Professional training courses for the Life Sciences and Intellectual Property Sectors
Management Forum is an internationally renowned training provider organising professional conferences, seminars and in-house courses for professionals and companies in the Life Sciences and Intellectual Property sectors. With their growing programme portfolio, training specialists at Management Forum aim to provide...
Request information - obligation free
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Find out more about this Clinical Quality Management Systems course - simply fill out your details:
There are no reviews available yet.
Are you curious about the L&D strategies of some of the U.K.'s top companies?
Find out what they're up to in findcourses.co.uk's second annual U.K. L&D Report!