Computer System Validation for Clinical Operations
Book a session
|23/10/2023||Computer System Validation for Clinical Operations||Brussels||EUR 1775.00||Book|
|If you would like to have this course as an in-house session click here|
About this course
Reasons to attend
Computer System Validation (CSV) in the past often has been anticipatedas an obscure IT topic. However, the addendum of ICH E6 stresses not only the need for validation, data integrity, and data privacy, but also indicates that this is not only an IT issue anymore: "The responsibilities of the sponsor, investigator and other parties with respect to the use of the computerized systems should be clear, and the users should be provided with training in the use or the systems."
Additionally, new technologies (e.g. cloud computing in its different forms) and increased outsourcing to Software as Service vendors prove to be challenging to remain in control of the data.
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
- This course has been granted PharmaTrain Recognition
Classroom:2-Day face-to-face: 09:00 - 17:00
Online:4 webinar sessions of 3 hours
The course provides an overview of the regulatory requirements, guidance documents, and best practices regarding computer system validation in a GCP environment. It is designed to assist those working in clinical operations to ensure that their data is secure and can be trusted.
The course covers not only the typical CSV processes (including GAMP 5) and the responsibilities of the different stakeholders, but also IT security and some basic European data privacy requirements are in scope.
Lectures provide sound knowledge regarding the validation of all kinds of computerized systems and devices while interactive workshops & cases will assist participants to apply this knowledge to the needs of their own organizations. We have added a second part to this program, to include more practical sessions on the importance of using Software as a Service, devices, and digital signatures especially with regard to archiving and record retention.
Before going to this course "CSV" was a dark bow for me. So with this training and also with the expertise of our trainer, I'm able to understand almost every thing when people are talking about computer system validation - The training was very interesting thanks to Marc. With his expertise, he explains us the trick of CSV using several studies cases