Course overview
Regulators in both Europe and the US expect organisations involved in clinical development to have an effective Clinical Quality Management System (CQMS) in place, even though there is no single, harmonised regulation that defines exactly what that system should look like.
As a result, many organisations struggle to interpret and apply overlapping requirements from sources such as ICH Q10, ICH GCP (R2 and R3), ISO quality principles, and regulatory guidance on data governance and computerised systems. CQMS arrangements are often fragmented, inconsistently applied, or poorly documented, leaving teams exposed during inspections.
This course focuses on what regulators actually expect to see in practice, and how to implement and maintain a proportionate, inspection-ready CQMS that works in real clinical development environments. The emphasis is on practical application rather than theory.
CPD Hours: 12
Course Content
- Day 1
- Overview of CQMS landscape
- What is clinical quality and CQMS?
- Proposed CQMS framework
- The Components of a CQMS
- Quality by design (QbD)
- Day 2
- QMS - compliance deficiencies
- Feedback from regulators
- Balancing strict regulations and progress in research
- Documentation supporting CQMS
Speakers
Laura Brown
Dr Laura Brown is an independent pharmaceutical quality assurance, management and training consultant and former Course Director of the MSc in Clinical Research at Cardiff University.
She has over 25 years’ experience working in quality assurance and the management of international clinical trials, across both industry and academia. Laura has worked in senior QA roles and with a range of organisations including GSK, Hoechst Marion Roussel, Good Clinical Research Practices, and Phoenix International.
Much of Laura’s work has focused on helping companies and clinical teams make quality systems work in practice - not just on paper. She has supported pharmaceutical companies, CROs, suppliers, and academic institutions with the development and improvement of quality management systems, inspection readiness, and day-to-day compliance.
Laura holds an MBA with a specialisation in project management, and her teaching and training style is practical and experience-led, drawing on real examples from clinical research rather than theory alone.
