This one-day workshop is designed to preparation for GCP Audit & Inspections for the NHS / Universities.

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Who Should Attend

This workshop is designed for NHS/ Academic staff working in clinical trials governed by the ‘Medicines for Human use (Clinical Trials) Regulations’. R&D staff, Investigators, research nurses, monitors, trial managers, project managers and site staff will find this course of benefit.

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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:    

• Describe the steps involved in the audit/inspection process
• Identify a project manager to manage the preparation audit/process
• State the key tasks in preparing their trials and/or departments for audit /inspection
• Develop an action plan for interview preparation
• Initiate management of corrective actions and preventative actions
• As it is only 1 day, pre-reading is required prior to attendance.

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