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Principles of Clinical Quality Assurance Audits 2026

A two days Virtual Open Training by the Quality Working Party

Description

Event Training
Type Virtual Event
Language English
Date(s) 23 & 24 Mar. 2026
Day(s) 2 Day(s)
Duration 8 Hours / Day

This introduction to the Principles of Clinical Quality Assurance Auditing has been developed to cover the principles of GCP and how they can be applied to clinical trial audits including computerised systems and data integrity.

Updated this year to include considerations for the use of AI and extended data governance, this interactive on-line workshop is developed and hosted by three leading quality professionals, with broad experience of clinical trials in Europe, the UK and USA.

With a focus on ICH GCP E6(R3), delegates will be given the opportunity to understand how it can be applied to individual audits and audit programmes using a risk-based approach.

The course includes points to consider for face-to-face audits and those conducted remotely, and, an evaluation of audit findings and proposed corrective and preventative actions (CAPA).

With an open forum for discussion, the course has been developed as an introduction for beginners, but has also been used as a refresher for those with experience, or wanting to develop their existing skills.

Given the extensive use of electronic systems and digital data collection tools in today’s clinical trials, this workshop includes key points to consider for computerised systems during routine clinical trial audits, as well as an overview of data integrity and data governance considerations.

By the end of the session, delegates will be able to:

  • Describe the Principles of Good Clinical Practice and explain the changes arising from the adoption of ICH GCP (Revision 3)
  • Apply GCP principles to clinical trial audit planning, conduct and reporting
  • Critically appraise computerised system validation documentation
  • Evaluate data integrity based on an understanding of fundamental data attributes
  • Appreciate the potential advantages and pitfalls of AI use in Clinical development

Trainers:

  • Louise Mawer, Mirabilitas Ltd
  • Kathleen Williams, KEW Quality Ltd
  • Trev Simmons, TS CSV QA Ltd

EFGCP Certificate: Principles of Clinical Quality Assurance Audits

A minimum number of registrants is necessary to run this course. As soon as the threshold is reached, all registered participants will be informed that the course is confirmed. Information on the number of registered participants can be found on our Website’s Dedicated page.

Minimum Number of Participants: 6
Maximum Number of Participants: 24

 

Programme

Monday 23 March 2026
09:15 Opening of the Training
09:30 Introduction & Welcome
10:15 GCP Update - A comparison of ICH E6(R2) and (R3) - The use of AI in clinical development - A look to the year ahead (ICH GCP Annex 2, UK Clinical Trial Regulations)
11:00 Break
11:15 GCP Audit Principles - An overview of auditing principles & practices - On-site and remote audit considerations - Yes or N-AI?
12:15 Lunch
13:00 Computerised System Validation Principles & Practices (Part 1) - Points to consider in computerised systems validation - ICH GCP E6(R3) Data Governance and EMA GCP Computerised System Guidelines (including expectations for Software as a Service)
14:00 Routine GCP and Clinical Trial Audits - Different types of GCP audit and how audit programmes are developed using a risk-based approach - Discussion on applying GCP principles to risk-based audit planning
15:15 Break
15:30 Computerised System Validation Principles & Practices (Part 2) Interactive discussion using a Case Study - Key records and evidence for audit - Role of the Sponsor in GCP
16:45 Summary - Discussion, Questions & Answers - Workshop set-up and scenarios for Day 2 - Preparation by delegates for Day 2
17:30 End of Day 1
Tuesday 24 March 2026
09:15 Opening of the Training
09:30 Welcome & Recap from Day 1 - Discussion, Questions & Answers - Workshop set-up and scenarios for Day 2
10:00 Auditing Computerised Systems - Overview of common computerised systems used in clinical trials - Points to Consider when planning GCP computer system audits
11:15 Data Integrity in Audit Practice - An introduction to data integrity applied to clinical trial audits - Regulatory perspectives on data integrity
12:15 Lunch
13:00 Workshop This two part workshop is designed to identify the key elements of a finding, and evaluate audit responses - Evaluation of the audit finding - Evaluation of the auditee response - Discussion
15:15 Break
15:30 Final Q&A Your opportunity to share your thoughts, questions and experiences in our last session topics, may include - Consideration of electronic systems issues and challenges - GCP & data integrity in GCP audits - Audit challenges
16.30 Course Summary & MCQ Test
17.30 End of Training