This one-day workshop is linked to the workshop entitled ‘Good Clinical Practice Audits – A Practical Introduction’. Attending both workshops is not mandatory, however, it is encouraged as GCP Audits are part of the Quality Management System (QMS). This workshop will include more detail on managing quality systems and systems audits, whereas the other workshop is based around site/trial-specific GCP audits.

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 or R&D staff. Management staff who supervise auditors or managing quality systems for research activity, or clinical research staff preparing for GCP audit or GCP inspection, will also 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:

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• Define the purpose of a quality management system
• Develop a QMS strategy for your department, facility or organisation
• Ensure Standard Operating Procedures (SOPs), work instructions and guidance documents are valid and operational
• Plan a gap analysis or a systems audit
• Manage non-conformances, deviations and create effective corrective actions and preventative actions in response
• Understand when it’s appropriate to undertake a Root Cause Analysis (RCA) in clinical research

 

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