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Clinical Quality Management Systems Training Course

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

17-18 Nov 2022

& 16-17 Mar 2023 , 6-7 Jul 2023 , 16-17 Nov 2023

Book or reserve now

Details

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

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

Presenters

Laura Brown (More...)

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.

Laura Brown (More...)

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), 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 and regulatory requirements in clinical trials in the pharmaceutical industry. She has worked in senior positions for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality systems including data protection and data integrity in clinical trials. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on pharmaceutical regulatory issues in clinical trials

Book now

Book or reserve now

NEW higher discounts for booking multiple places - 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

Choose your date below - or reserve your place with no obligation for 7 days at ipi.academy: Reserve now
17-18 Nov 2022
Live webinar
09:30-17:00
UK (London)
17-18 Nov 2022
Live webinar
09:30-17:00
UK (London)
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 13 Oct*
Enrol now
to attend Live webinar
16-17 Mar 2023
Live webinar
09:30-17:00
UK (London)
16-17 Mar 2023
Live webinar
09:30-17:00
UK (London)
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 9 Feb 23*
Enrol now
to attend Live webinar
6-7 Jul 2023
Face-to-face, Rembrandt Hotel London
09:00-17:00
UK (London)
6-7 Jul 2023
Face-to-face
Rembrandt Hotel London
09:00-17:00
UK (London)
GBP 1,499 1,299
EUR 2,149 1,869
USD 2,449 2,137
Until 1 Jun 23*
Enrol now
to attend Face-to-face
Rembrandt Hotel London
  • 2 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
16-17 Nov 2023
Live webinar
16-17 Nov 2023
Live webinar
GBP 1,299 1,099
EUR 1,869 1,589
USD 2,129 1,817
Until 12 Oct 23*
Enrol now
to attend Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code. As such, discounts for the 2nd/3rd/4th attendees are based on the full price of the course. Please contact us for pricing if you wish to send more than 4 delegates.

Continuing professional development

This course qualifies for 12 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

Previous customers include...

  • BIOXODES SA
  • Blue Earth Diagnostics
  • BTG (Biocompatibles)
  • GARDP
  • GELITA MEDICAL GmbH
  • Laboratorios CINFA SA
  • MONİTÖR MEDİKAL ARAŞTIRMA VE DANIŞMANLIK TİC.LTD.ŞTİ. Şişli/İstanbul
  • Takeda Pharmaceuticals International AG

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, Nov 19