One day workshop

Who Should Attend

This workshop is designed for NHS / Academic staff who are involved in managing quality systems which comply with the ‘UK Policy Framework for Health & Social Care Research’ and/or the regulations required for clinical trials of medicinal products or medical devices. For example, quality assurance managers, research governance managers, clinical research associates, monitors, trial managers, project managers and R&D staff. Management staff responsible for supervising quality assurance staff or managing oversight of research activity 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 computer systems validation (CSV) and understand the regulatory requirements
• Understand how to apply CSV requirements to Electronic Healthcare Records in a hospital setting
• Plan and undertake a CSV risk assessment
• Develop a validation master plan
• Understand the requirements of user acceptance testing
• Develop a validation report
• Assess your current organisational strategy regarding the validation of Electronic Healthcare Records
• Undertake a high-level gap analysis and initiate the computer systems validation process for key hospital systems

 

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