One day workshop for the NHS / Universities.

Who Should Attend

This workshop is designed for NHS/Academic/Non-commercial  IT staff and system owners as well as QA staff responsible for GxP systems, who want to understand regulatory expectations for validation, and pragmatic solutions.

​

Description

The course follows on from our workshop entitled ‘ Computer System Validation and Electronic Health Records’.

Please note this 2nd workshop is a little more technical and will cover in more detail, the topic areas such as:

• 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

​

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