Clinical Quality Management Systems

Course Overview

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 effectively implement and integrate these QMS standards, including ISO 9000 principles, ICH10 for CQMS and ICH R2 CQMS requirements.

This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality. The interactive programme will discuss the proposal for a new industry best practice CQMS framework as well as the new EMA TMF guideline requirements and implications for CQMS.

Benefits of attending:

• Understand developing regulatory requirements for clinical quality management systems (CQMS)
• Review the new proposed CQMS framework
• Consider best practice in key CQMS areas including risk-based elements, CAPA, documentation and new EMA requirements for TMF systems
• Discuss the importance of key performance indicators (KPIs) in 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 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.

Programme Day-one

Introductions and objectives

What is clinical quality and CQMS?

• Quality principles and definitions
• The new proposed CQMS framework
• How does the CQMS fit within the organisation’s QMS?
• Regulatory drive for CQMS

New industry 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?

New ICH E8 Guideline – general consideration

• Designing quality into clinical studies
• Critical quality factors

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 CQMS including new EMA requirements for the TMF

• What documents should be in place?
• New EMA requirements for the TMF
• Data integrity considerations

Programme Day-two

Importance of KPIs in your QMS and governance

• Documentation of KPIs and key performance tolerance levels
• Implementing quality tolerance limits (QTL) – examples and tips
• Management review and governance of a CQMS

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

Issues and CAPA management

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

QMS – technology solutions

• Examples of technology solutions and support technologies for CQMS