Clinical QMS Compliance
Dr. Laura Brown, Ph.D., MBA, Diploma Clinical Sciences, is an independent QA and Training Consultant in the Pharmaceutical Industry as Managing Director LB Training and Development Ltd., Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff, and Course Director MSC Regulatory Affairs, TOPRA.
Laura has more than 20 years’ experience of drug development and quality assurance in the pharmaceutical industry, including writing SOPs and auditing internationally and helping to prepare companies for inspection.
Laura Brown has held a number of international and senior management QA positions in the pharmaceutical industry including as an Associate Director with a leading GXP audit consultancy preparing and managing SOPs. She has worked for several international companies including Glaxo Wellcome, Hoechst Marion Roussel, and Phoenix International.
Laura is the author of a chapter on “Training QA staff” in the leading GXP book: “Good Clinical, Laboratory and Manufacturing Practices”. She is also co-author of several books including “Developing the Individual” and “Project Management for the Pharmaceutical Industry”. She has regularly lectured at conferences and on training courses on SOPs and quality issues.
Laura developed an e-learning module: “How to Prepare for Audit and Inspection” for Zenosis (A regulatory commercial e-learning training organization and is editor of an e-learning SOP series).
Laura runs many training courses both on public courses and in-company on topics including pharmaceutical project management, understanding the pharmaceutical industry/drug development, writing and managing SOPs, Regulatory requirements for Clinical Trials, the clinical trial directive, managing clinical trials, QA Management and business skills, how to prepare for audit and inspection, how to audit etc.
Currently pharmaceutical and medical device industry guidance for quality in clinical development is fractured across multiple documents from multiple sources. Also, with the implementation of ICH GCP R2, it is expected that the CQMS should be risk-based.
Regulatory inspectors including those in Europe, the FDA and UK’s MHRA now expect a CQMS to be in place. However, there is no industry-wide conceptual framework for clinical Quality Management that aims to address quality and monitor and improve performance in complex clinical development-specific environments. More developed systems exist in other departments such as manufacturing and pharmacovigilance.
Organizations are struggling to implement the QMS standards such as ISO 9000 principles, ICH 10 for CQMS and also some ICH R2 CQMS requirements are proving challenging. Since there is currently no harmonized regulatory guidance defining elements of a CQMS framework there is a proposal for a new ICH guideline to cover CQMS.
This session is designed to help in both the compliance with inspectors expectations for CQMS and share best practice for CQMS including a new proposed unified standard CQMS framework.
- Understand clinical Quality Management Systems (CQMS)
- Review the new proposed CQMS framework
- Discuss the importance of Key Performance Indicators (KPIs) in your CQMS
- Ensure compliance with CQMS expectations of inspectors
- What is a Clinical Quality Management System?
- Regulatory drive for CQMS: ICH Q10, EMA Quality Systems, ISO 900, ISO Devices, FDA perspective, ICH E6 (R2)
- Proposed ICH CQMS – CQMS Framework
- What are the components of a CQMS
- Compliance Deficiencies including CQMS
- What are inspectors looking for?
- Feedback from the regulators - hot inspection topics and trends
- Documentation supporting quality and Data Integrity in CQMS
- What documents which should be in place?
- Importance of Key Performance Indicators (KPIs) in your QMS
- Governance of CQMS
- The role of Senior Management
- Management review
Course Level - Basic and Intermediate
Who Should Attend
This course is aimed at anyone working in clinical research and associated functions including regulatory affairs, document management etc who need to know how to establish, maintain, monitor and improve a modern CQMS that focuses on product quality, compliance to GCP and the needs of the business.
This course is also of value to any Quality Professional, especially those working in Quality Assurance and Quality Improvement roles in clinical research, management responsible for the 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 for CQMS and also anyone wanting to know about the new harmonized standard proposed for CQMS.