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Principles of Clinical Quality Assurance Audits 2025

A two days Virtual Open Training by the Quality Working Party

Description

Event Training
Type Virtual Event
Language English
Date(s) 13 & 14 Jan. 2025
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 both computerised systems and data integrity.

This interactive on-line workshop is developed and hosted by three experienced leading quality professionals, with broad experience of clinical trials in Europe, the UK and USA.

With a primary focus on ICH GCP, delegates will be given the opportunity to understand GCP legislation and how it can be applied to individual audits and audit programmes using a risk-based approach. The course includes both points to consider for face-to-face audits and those conducted remotely. With an open forum for discussion, the course has been used as an introduction for beginners, and a refresher for those with experience, or wanting to develop their existing skills.

Given the ubiquity of electronic systems and digital data collection tools in today’s clinical trials, this workshop includes an introduction to computerised system validation and key points to consider during routine clinical trials audits, as well as an overview of data integrity and application of GXP Data Integrity Guidance.

Trainers:

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

EFGCP Certificate: Principles of Clinical Quality Assurance Audits

  • Principles of GCP
  • Principles of GCP Audits
  • ICH GCP E6 (R3)
  • Routine GCP and Clinical Trials Audits
  • Audit Planning
  • Computerised System Validation Principles & Practices
  • Audit Planning and Computerised Systems
  • Data Integrity in Audit Practice

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

Update: The minimum amount of participants has been reached, this training is confirmed.

 

Programme

Monday 13 January 2025
09:30 Opening of the Training
09:45 Introduction & Welcome
10:30 Principles of GCP
An overview of ICH GCP (R2 & R3)
A world of trial legislation
11:00 Break
11:15 GCP Audit Principles
An overview of Auditing Principles & Practices
On-site and Remote Audit Considerations
12:15 Lunch
13:00 Computerised System Validation Principles & Practices (Part 1)
An introduction to computerised systems validation
Comparison of V-Model/System Development Lifecycle and Agile methodologies
14:00 Routine GCP and Clinical Trial Audits
Different types of GCP audit and how audit programmes are developed using a risk-based approach
Applying GCP principles to audit planning
15:00 Break
15:15 Computerised System Validation Principles & Practices (Part 2)
Key records and evidence for audit
Role of the Sponsor in GCP
16:30 End of Day 1: Summary
Discussion, Questions & Answers
Workshop set-up and scenarios for Day 2
Preparation by delegates for Day 2
Tuesday 14 January 2025
08:45 Opening of the Training
09:00 Welcome & Recap from Day 1
Discussion, Questions & Answers
Workshop set-up and scenarios for Day 2
09:30 Audit Planning Workshop (1)
Delegates will have the opportunity to plan an example GCP audit, to be conducted either face-to-face or remotely, using case studies and present their plan for discussion and development
11:00 Workshop Feedback
Delegates share their plans and critically evaluate the strengths and weaknesses of their audit process
12:00 Lunch
12:45 Audit Planning and Computerised Systems
Overview of common computerised systems used in clinical trials
Points to Consider when planning GCP audits
13:30 Data Integrity in Audit Practice
An introduction to data integrity applied to clinical trial audits
Regulatory perspectives on data integrity
14:30 Audit Planning Workshop (2)
Consideration of electronic tools and systems, GCP & data integrity in GCP audits
Common GCP Computerised System examples – delegates will have the opportunity to propose methods for review of common GCP electronic systems
Group feedback and discussion on systems and methods
16:30 Course Summary & MCQ Test