Principles of Clinical Quality Assurance Audits 2025
A two days Virtual Open Training by the Quality Working Party
Description
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
In case the minimum number of participants is not reached by the 30th of November 2024, the Training will be Cancelled, and all registered participants will be fully reimbursed (should they have already paid).