Presented by
Management Forum

Clinical Quality Management Systems

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

18-19 Nov 2021 + 2 more dates

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  • Format: Live online
  • CPD: 12 hours for your records
  • Certificate of completion

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.

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The Clinical Quality Management Systems course will cover:

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?

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

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

Key consideration for computer validation

  • Essentials of validation
  • What are inspectors looking for?

QMS – technology solutions

  • Examples of technology solutions and support technologies for CQMS

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Laura Brown

Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and senior lecturer for the MSc in Clinical Research at the School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials. She has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and has consulted with numerous pharmaceutical companies and suppliers to the pharmaceutical industry as well as academic institutions concerning quality management. Laura has an MBA with specialisation in project management, including quality assurance.

More details

Book Clinical Quality Management Systems Live online training

18-19 Nov 2021

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Course code 11139

  • GBP 1,299
  • EUR 1,859
  • USD 2,098

In your basket 

26-27 May 2022

Live online

09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 11632

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 21 Apr

In your basket 

17-18 Nov 2022

Live online

00:00-00:00 UK (London) (UTC+00)
01:00-01:00 Paris (UTC+01)
19:00-19:00 New York (UTC-05)
Course code 11767

  • GBP 1,099 1,299
  • EUR 1,579 1,859
  • USD 1,786 2,098

Until 13 Oct

In your basket 

Reviews of IPI's Clinical Quality Management Systems training course


I really enjoyed the course. Content was very interesting, presentation material well done and it was possible to ask lots of questions. Laura is a very experienced speaker and she knows how to get the audience's attention.

Nov 14 2019

Yvonne Wiggenhauser
Process Document Manager , Takeda Pharmaceuticals International AG

Switzerland

  • GARDP
  • Takeda Pharmaceuticals International AG

UK

  • Blue Earth Diagnostics
  • BTG (Biocompatibles)

Belgium

  • BIOXODES SA

Germany

  • GELITA MEDICAL GmbH

Turkey

  • MONİTÖR MEDİKAL ARAŞTIRMA VE DANIŞMANLIK TİC.LTD.ŞTİ. Şişli/İstanbul

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Multiple colleagues?
Talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra BEER
Training expert

+44 (0)20 7749 4749

inhouse@ipi.academy