Principles of Clinical Quality Assurance Audits 2023

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 in consideration of 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 European and UK requirements over two days, 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.

As few clinical trials are successfully completed today without the use of electronic data capture systems and data collection tools, the workshop includes an introduction to computerised system validation and 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

Certificate: Principles of Clinical Quality Assurance Audits

• Principles of GCP
• Principles of GCP Audits
• 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 number of participants is has been achieved, this event is confirmed.