Computer Validation: Maintaining the Validated State 16-17 October 2008 Prague, Czech Republic 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 1690,--) Book this option: ECA Members (EUR 1521,--) Book this option: EU GMP Inspectorates (EUR 845,--) Book this option: APIC Members (does not include ECA membership) (EUR 1605,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Background Today, the validation of computerised systems is a required and lived practice in the pharmaceutical industry. Even though the first validation only takes a short time in the life cycle of a system, the current regulations and industry guides deal above all with this phase. However, the greatest part of the life cycle is represented by daily operation. How can the validated state be maintained during routine operation? What is required and how can these requirements be put into practice? Experts from the pharmaceutical industry and from the GAMP Committee will give you answers to these questions. Besides, you will learn to establish a GMP-compliant change control system for your computerised system. 3 Good reasons why you should attend: - You will get to know methods for maintaining the validated state of a computerised system in a GMPcompliant way - You will learn how to ensure the security of your data in the short, medium and long term - In 5 workshops, you will implement the theoretical knowledge practically and discuss suitable solution strategies with your colleagues