One day workshop for the NHS / Universities delivered with the use of presentations, group discussions and interactive exercises.

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Who Should Attend

workshop is designed for staff working with/using/managing computer systems and
ensuring they are fit for purpose in clinical trials. You do not need expertise in CSV to attend as we aim to tailor the workshop to everyone’s level of experience. IT staff and system owners as well as QA staff responsible for GxP systems, Trial Managers and R&D Staff who want to understand regulatory expectations for validation, and pragmatic solutions will benefit from the workshop.

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Description

• Summary of the regulations re CSV and expectations at inspection

• Explore Risk-based validation approaches to CSV including a summary of GAMP

• Expectation for supplier assessments, e.g. for EDC procurement

• Validation of study builds using EDC

• Dealing with complex interrelated systems and associated change control

• Data integrity challenges, e.g. data ex

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