As a specialist for the validation of computerised systems, the event will provide you with
Suggestions on how current regulatory guidance on computerised systems relating to data integrity, critical thinking and CSA (Computer Software Assurance) can be put into practice
Real-life examples of how validation effort can be scaled according to risk-based approaches
Answers to specific questions, e.g. on source code review or on creating specification documents
The opportunity to bring questions from your own practice up for discussion
Background
The V-model has become a standard worldwide methodology for the validation of computerised systems. Regulatory requirements, as well as industry guidelines, like GAMP®5 2nd Edition, are orientated towards this model. In practice, you as a validation specialist will want to know how to apply this model to current and increasingly complex validation projects.
Target Group
The Master Class is directed at employees from
IT
Production
Engineering
Quality Assurance
Quality Control
Participants should already have gained experience in the validation of computerised systems, and preferably will have also attended a basic CSV Course.
Date / Venue / Presentations / Certificate
Date Wednesday, 4 June 2025, 09.00 h – 17.30 h (Registration and coffee 08.30 h - 09.00 h) Thursday, 5 June 2025, 08.30 h – 17.30 h Friday, 6 June 2025, 08.30 h – 16.00 h
The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site.
After the event, you will automatically receive your certificate of participation.
Testimonials
Seminar Programme as PDF