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 GCP R2 and R3 CQMS requirements.
This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality, including EMA guidance on computerised systems and ICH GCP R3 data governance.
Benefits of attending:
- Understand developing regulatory requirements for clinical quality management systems (CQMS)
- Review proposed CQMS framework
- Consider best practice in key CQMS areas
Certification:
- CPD: 12 hours for your records
- Certificate of completion
Agenda
Day 1
What is clinical quality and CQMS?
- Quality principles and definitions
- Proposed CQMS framework
New industry CQMS framework
- The components of a CQMS
- Quality by design - what does it mean and how does it apply to clinical research and the CQMS?
QMS - compliance deficiencies
- What are inspectors looking for?
- Feedback from the regulators - hot inspection topics and trends
- Balancing strict regulations and progress in research
Documentation supporting CQMS
Enrol or reserve
Day 2
Importance of KPIs in your QMS and governance
- Documentation of KPIs and key performance tolerance levels
- Quality tolerance limits (QTL)
- Management review and governance of a CQMS
Risk-based component of CQMS
- Risk methodologies to include in CQMS
- ICH GCP R2 and R3 risk-based elements of a CQMS
Vendor oversight
- Outsourcing and partnership
- Demonstrating and documenting vendor oversight to inspectors
- Metrics and KPIs
Issues and CAPA management
- Correction, corrective action, preventive action and root cause analysis
Key consideration for computer systems and governance and validation
- Essentials of validation
- EMA guidance on computer systems
- ICH GCP R3 governance
- What are inspectors looking for?
- AI
QMS - technology solutions
- Examples of technology solutions and support technologies for CQMS
Speakers
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of CardiffDr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
Who Should Attend
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.
