Clinical Quality Management Systems

A two-day course that will ensure you to comply with new regulatory requirements

14-15 Nov 2019

& 18-19 May 2020

GBP 1,499
EUR 2,099
USD 2,338

Book now

Course overview

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:

  • 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 inspectors’ expectations of your CQMS

Who will the course benefit?

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.

Programme day-one

What is a clinical QMS?

  • Quality principles and definitions
  • The new proposed CQMS framework
  • How does the CQMS fit within the organisation’s QMS?
  • Regulatory drive for CQMS: ICH Q10, EMA Quality Systems, ISO 900, ISO 14385 Devices, ICH E6 (R2), FDA perspective

Proposed ICH 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?

CQMS – 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 quality and data integrity in CQMS

  • What documents should be in place?
  • Data integrity considerations

Importance of KPIs in your QMS

  • Documentation of KPIs and key performance tolerance levels
  • Implementing quality tolerance limits
  • (QTL) – examples and tips

Programme day-two

Risk-based component of CQMS

  • Risk methodologies to include in CQMS
  • ICH GCP R2 risk-based elements of a CQMS

Vendor oversight

  • Outsourcing and partnership
  • Demonstrating and documenting vendor oversight to inspectors
  • Metrics and KPIs

Investigator oversight

  • What is expected?
  • Demonstrating and documenting vendor oversight to inspectors

CAPA elements of CQMS

  • Correction, corrective action, preventive action and root cause analysis

QMS – technology solutions

  • Examples of technology solutions and support technologies for CQMS

Final discussion and close of meeting


Laura Brown

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.

Book now

14-15 Nov 2019
14-15 Nov 2019 Rembrandt Hotel, London GBP 1,499.00
EUR 2,099.00
USD 2,338.00
+ VAT @ 20.00%
Enrol now
18-19 May 2020
18-19 May 2020 Venue not yet confirmed
+ VAT @ 20.00%
Online registration unavailable: this date is nearing full capacity; please call us on 020 7749 4730 to register.

Previous customers include...

  • BTG (Biocompatibles)