One day workshop, which is linked to a second workshop entitled ‘Successful Quality Management in Clinical Research’. Attending both workshops is not mandatory but encouraged as Good Clinical Practice (GCP) Audits are part of the Quality Management System. This workshop will include more detail on site/trial specific GCP audits and the second workshop will include further information on GCP audits on systems.

Who Should Attend

This workshop is designed for NHS / Academic staff whose role involves auditing and quality management in clinical research either governed by the ‘UK Policy Framework for Health & Social Care Research’ and/or governed by the regulations required for clinical trials of medicinal products or medical devices. For example auditors, monitors, QA staff, research nurses, trial managers, project managers, R&D staff. Management staff involved with supervising auditors, or managing quality systems of research activity or clinical research staff preparing for GCP audit or GCP inspection will find this workshop of interest.

Description

It will be an interactive day with a combination of presentations, discussions and workshop. By the end of this workshop, participants will be able to:

 

• Define the purpose and types of GCP audits
• Develop the scope of the GCP audit
• Plan a trial specific GCP audit
• Record and grade findings in an GCP audit report
• Review responses and close out GCP audit

 

As it is only 1 day pre reading is required prior to attendance.