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Clinical Quality Management Systems Training Course

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

★★★★★ "Very knowledgeable and presented information in a concise, easy to understand way"

19-20 September 2024 »
from £1099

Need help?  Enrol or reserve

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 GCP R2 and R3 CQMS requirements.

This course will provide essential information and guidance to help you achieve regulatory compliance in this evolving area of clinical quality, including EMA guidance on computerised systems and ICH GCP R3 data governance.

Benefits of attending:

  • Understand developing regulatory requirements for clinical quality management systems (CQMS)
  • Review proposed CQMS framework
  • Consider best practice in key CQMS areas

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

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.

Enrol or reserve

The Clinical Quality Management Systems course will cover:

What is clinical quality and CQMS?

  • Quality principles and definitions
  • Proposed CQMS framework

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?

QMS – 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

Enrol or reserve

Importance of KPIs in your QMS and governance

  • Documentation of KPIs and key performance tolerance levels
  • Quality tolerance limits (QTL)
  • Management review and governance of a CQMS

Risk-based component of CQMS

  • Risk methodologies to include in CQMS
  • ICH GCP R2 and R3 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 systems and governance and validation

  • Essentials of validation
  • EMA guidance on computer systems
  • ICH GCP R3 governance
  • What are inspectors looking for?
  • AI

QMS – technology solutions

  • Examples of technology solutions and support technologies for CQMS

Enrol or reserve

Laura Brown
LB Training and Development Ltd

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

NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

  • 30% off the 2nd delegate*
  • 40% off the 3rd delegate*
  • 50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

19-20 September 2024

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 14023

  • GBP 1,099 1,299
  • EUR 1,589 1,869
  • USD 1,817 2,129

Until 15 Aug

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Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Clinical Quality Management Systems training course

Very knowledgeable and presented information in a concise, easy to understand way

Jan 25 2024

Joanna Faraj
Quality System Manager, Mitsubishi Tanabe Pharma Europe

Jan 25 2024

Very knowledgeable and presented information in a concise, easy to understand way

Joanna Faraj
Quality System Manager, Mitsubishi Tanabe Pharma Europe

Nov 14 2019

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.

Yvonne Wiggenhauser
Process Document Manager , Takeda Pharmaceuticals International AG


  • HilleVax GmbH
  • Ibsa Institut Biochimique Sa
  • Takeda Pharmaceuticals International AG

United Kingdom

  • Blue Earth Diagnostics
  • BTG (Biocompatibles)
  • Destiny Pharma
  • Mitsubishi Tanabe Pharma Europe






  • Basic Pharma Manufacturing


  • ClinActis Pte Ltd


  • Laboratorios CINFA SA



Enrol or reserve

Run Clinical Quality Management Systems Live online for your team

2 days

Typical duration

Pricing from:

  • GBP 800
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online


We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, 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

Aleksandra BEER
Training expert

Yesim Nurko

Training expert

+44 (0)20 7749 4749