Currently there is no harmonised regulatory guidance for clinical quality management – 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 the QMS standards, including ISO 9000 principles, ICH10 for CQMS and ICH R2 CQMS requirements. Without an industry-wide framework for clinical quality management, there is a proposal for a new ICH guideline in this area.
This course will help achieve regulatory compliance for CQMS, enabling you to share best practice, as well as discuss the new proposal for a unified standard CQMS framework.
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 clinical QMS 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 to know about the new harmonised standard proposed for CQMS.
What is a clinical QMS?
Proposed ICH CQMS framework
CQMS – compliance deficiencies
Documentation supporting quality and data integrity in CQMS
Importance of KPIs in your QMS
Risk-based component of CQMS
CAPA elements of CQMS
QMS – technology solutions
Final discussion and close of meeting
Dr 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.