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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

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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.

Presenter

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.

Book now

Book 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
17-18 Nov 2022
Live webinar
17-18 Nov 2022
Live webinar
GBP 1,299 1,099
EUR 1,859 1,579
USD 2,098 1,786
Until 13 Oct*
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