Computer Systems Validation Master Class 20-22 June 2012 Hamburg, Germany Please click here to view the program of this conference or course To book for this program, just click on the option: Book this option: Non-ECA Members (EUR 1990,--) Book this option: ECA Members (EUR 1790,--) Book this option: EU GMP Inspectorates (EUR 995,--) Book this option: APIC Members (does not include ECA membership) (EUR 1890,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Objectives As a specialist for the validation of computerised systems, this event will provide you with Suggestions on how the current regulatory developments have to be put into practice Real-life examples of how the validation efforts can be controlled by means of risk analysis Answers to specific questions, like e.g. on source code review or on drawing up design specifications The opportunity to bring questions from your own practice up for discussion The event is interactive and encourages the active participation of all attendees. Lectures alternate with workshops and discussion sessions. Background The V model has become a worldwide standard in the validation of computerised systems. Regulatory requirements as well as industry standards, like e.g. GAMP®, are orientated towards this model. In practice, you as a validation specialist will often wonder in how far this model can be applied to your own validation projects. GAMP® is a trademark of ISPE http://www.ispe.org/gamp5