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 implement and integrate effectively these QMS standards, including ISO 9000 principles, ICH10 for CQMS and ICH R2 CQMS requirements.
This course will help you to achieve regulatory compliance in this evolving area of clinical quality. The programme will discuss the proposal for a new industry best practice CQMS framework as well as the new draft ICH E8 Guideline, requirements for building quality into clinical studies and examples of critical quality factors.
Benefits of attending:
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.
Introductions and objectives
What is clinical quality and CQMS?
New industry CQMS framework
New ICH E8 Guideline – general consideration
CQMS – compliance deficiencies
Documentation supporting quality and data integrity in CQMS
Importance of KPIs in your QMS
Risk-based component of CQMS
Issues and CAPA management
QMS – technology solutions
Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials