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Management Forum

Clinical Quality Management Systems Training Course

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

25-26 January 2024
+ 23-24 May 2024, 19-20 September 2024 »
from £1099

Need help? Enrol or reserve

Format: Live online
CPD: 12 hours for your records
Certificate of completion

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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

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:

Day 1
Day 2

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

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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

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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

25-26 January 2024

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 13544

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

Until 21 Dec

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

View basket

Not ready to book yet?

for 7 days, no obligation

23-24 May 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 14122

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

Until 18 Apr

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

View basket

Not ready to book yet?

for 7 days, no obligation

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

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

View basket

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 Switzerland
Process Document Manager , Takeda Pharmaceuticals International AG