Presented by
Management Forum
Clinical Quality Management Systems Training Course
A two-day course that will ensure you comply with new regulatory requirements.
16-17 November 2023
from £1099
- 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.
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
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.
Book Clinical Quality Management Systems Live online training
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
16-17 November 2023
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 12427
- GBP 1,099 1,299
- EUR 1,589 1,869
- USD 1,817 2,129
Until 12 Oct
- 2 days live online training
- Browser-based, no download usually required
- See presenters and interact with fellow attendees
- Download documentation and certification of completion
- Fair transfer and cancellation policy
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.
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
United Kingdom
- Blue Earth Diagnostics
- BTG (Biocompatibles)
- Destiny Pharma
Switzerland
- GARDP
- Takeda Pharmaceuticals International AG
Belgium
- BIOXODES SA
Germany
- GELITA MEDICAL GmbH
Spain
- Laboratorios CINFA SA
Turkey
- MONİTÖR MEDİKAL ARAŞTIRMA VE DANIŞMANLIK TİC.LTD.ŞTİ. Şişli/İstanbul
Run Clinical Quality Management Systems Live online for your team
2 days
Typical duration
Pricing from:
- GBP 800
- Per attendee
- 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:
