Our latest COVID-19 information - full Autumn programme of webinars now in place
  • Home
  • Clinical Quality Management Systems

Clinical Quality Management Systems Training Course

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

19-20 Nov 2020

& 17-18 May 2021 , 24-25 May 2021 , 18-19 Nov 2021 , 25-26 Nov 2021

Book 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

QMS – technology solutions

  • Examples of technology solutions and support technologies for CQMS

Presenter

Laura Brown (More...)

Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and course director 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

19-20 Nov 2020
Live webinar
19-20 Nov 2020
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 8 Oct*
Enrol now
to attend
Live webinar
17-18 May 2021
Live webinar
17-18 May 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 5 Apr 21*
Enrol now
to attend
Live webinar
24-25 May 2021
Face-to-face, (venue not yet confirmed)
24-25 May 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 12 Apr 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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
18-19 Nov 2021
Live webinar
18-19 Nov 2021
Live webinar
GBP 1,099.00
EUR 1,579.00
USD 1,786.00
Until 7 Oct 21*
Enrol now
to attend
Live webinar
25-26 Nov 2021
Face-to-face, (venue not yet confirmed)
25-26 Nov 2021
Face-to-face
(venue not yet confirmed)
GBP 1,299.00
EUR 1,819.00
USD 2,026.00
Until 14 Oct 21*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 2 days of 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

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

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...

  • Blue Earth Diagnostics
  • BTG (Biocompatibles)
  • GARDP
  • 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