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Clinical Quality Management Systems (CQMS): A Practical Guide to Inspection Readiness Training Course

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

★★★★★ "Very knowledgeable and presented information in a concise, easy to understand way"

23-24 March 2026
+ 17-18 September 2026 »
from £1299

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Course overview

Regulators in both Europe and the US expect organisations involved in clinical development to have an effective Clinical Quality Management System (CQMS) in place, even though there is no single, harmonised regulation that defines exactly what that system should look like.

As a result, many organisations struggle to interpret and apply overlapping requirements from sources such as ICH Q10, ICH GCP (R2 and R3), ISO quality principles, and regulatory guidance on data governance and computerised systems. CQMS arrangements are often fragmented, inconsistently applied, or poorly documented, leaving teams exposed during inspections.

This course focuses on what regulators actually expect to see in practice, and how to implement and maintain a proportionate, inspection-ready CQMS that works in real clinical development environments. The emphasis is on practical application rather than theory.

Browse our extensive selection of Life Sciences training courses for industry-leading insights into a range of topics. These include Medical Devices, IVDs, Biotech and Biopharma, Animal Health and Pharmaceutical training courses.

Benefits of attending

Understand current regulatory expectations for CQMS in clinical research and how they are applied in inspections
Recognise the key components of an effective CQMS and how they link together across the clinical lifecycle
Identify common CQMS weaknesses highlighted during regulatory inspections and how to avoid them
Apply risk-based thinking to CQMS design, oversight and documentation
Understand how data governance, computerised systems and vendor oversight fit within a CQMS
Feel more confident explaining and defending your CQMS to inspectors

Who should attend

This course is designed for professionals involved in clinical research who have responsibility for, or interface with, clinical quality systems, including:

Clinical research and clinical operations professionals
Quality assurance and quality management staff
Regulatory affairs and document management personnel
Study, programme and project managers
Those responsible for governance, oversight or inspection readiness
Service providers and study sites working within sponsor CQMS frameworks

The course is particularly useful for organisations implementing or refining a CQMS, teams preparing for regulatory inspections, and those seeking a practical update on ICH GCP R3-related CQMS expectations.

Enrol/reserve

This course will cover:

Day 1
Day 2

Overview of CQMS landscape

What is clinical quality and CQMS?

Quality Principles and Definitions
Core quality concepts
Relationship to ICH-GCP
Risk-based quality management

Proposed CQMS framework

New Industry CQMS Framework
Governance structures
Lifecycle approach
Integration with risk management
Recent industry developments

The Components of a CQMS

Quality policy and objectives
SOP hierarchy
Training and competency
Audit & CAPA systems
Metrics and oversight

Quality by design (QbD)

Definition and regulatory origin
Application in clinical research
Embedding QbD into CQMS

QMS - compliance deficiencies

What are inspectors looking for?
Common inspection findings
Systemic vs isolated issues
Data integrity focus
Oversight expectations

Feedback from regulators

Hot inspection topics and trends
Recent regulatory themes
Risk-based monitoring focus
Emerging global trends

Balancing strict regulations and progress in research

Innovation vs compliance
Digitalisation and AI
Proportionality in quality systems

Documentation supporting CQMS

Quality Manual
SOP structure
Quality plans
Audit documentation
Inspection readiness

Enrol/reserve

Laura Brown
Independent Pharmaceutical Consultant

Dr Laura Brown is an independent pharmaceutical quality assurance, management and training consultant and former Course Director of the MSc in Clinical Research at Cardiff University.
She has over 25 years’ experience working in quality assurance and the management of international clinical trials, across both industry and academia. Laura has worked in senior QA roles and with a range of organisations including GSK, Hoechst Marion Roussel, Good Clinical Research Practices, and Phoenix International.

Much of Laura’s work has focused on helping companies and clinical teams make quality systems work in practice - not just on paper. She has supported pharmaceutical companies, CROs, suppliers, and academic institutions with the development and improvement of quality management systems, inspection readiness, and day-to-day compliance.

Laura holds an MBA with a specialisation in project management, and her teaching and training style is practical and experience-led, drawing on real examples from clinical research rather than theory alone.

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

23-24 March 2026

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
05:30-13:00 New York (UTC-04)
Course code 16062

GBP 1,499
EUR 2,099
USD 2,399

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

17-18 September 2026

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 16334

GBP 1,299 1,499
EUR 1,819 2,099
USD 2,087 2,399

Until 13 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; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Clinical Quality Management Systems (CQMS): A Practical Guide to Inspection Readiness training course

good presenter.

Sep 18 2025

Hanne Storgaard Denmark
Clinical Quality Operations Lead- Suppliers, MSD Denmark

Sep 18 2025

Good presenter.

Hanne Storgaard Denmark
Clinical Quality Operations Lead- Suppliers, MSD Denmark

Jan 25 2024

Very knowledgeable and presented information in a concise, easy to understand way

Joanna Faraj United Kingdom
Quality System Manager, Mitsubishi Tanabe Pharma Europe

Jan 25 2024

Very knowledgeable and presented information in a concise, easy to understand way

Joanna Faraj United Kingdom
Quality System Manager, Mitsubishi Tanabe Pharma Europe

Nov 14 2019

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 Switzerland
Process Document Manager , Takeda Pharmaceuticals International AG