Computer Validation: Introduction to Risk Management 15 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 890,--) Book this option: ECA Members (EUR 811,--) Book this option: EU GMP Inspectorates (EUR 445,--) Book this option: APIC members (does not include ECA membership) (EUR 845,--)
At this conference we offer a Conference Exhibition. Please click here in order to view the registration form (PDF) for exhibitors.
Learning Goals You get to know the current risk management approaches of ICH Q9 and the GAMP®5 You become familiar with the latest methods and tools for risk analysis and can assess their relevance to practice in the validation of computerised systems You learn how the activities involved in the validation of computerised systems can be controlled efficiently by means of risk management In 4 workshops you can apply the procedures and discuss them Background The current GMP regulations and guidelines (ICH Q9, GAMP®5, draft EC-GMP Guide Annex 11 „Computerised Systems“) focus more and more on the topic of risk management. However, the regulations do not offer much concrete advice on how its principles should be translated into practice during the validation and operation of computerised systems. Therefore, it is the aim of this course to provide you with practice-oriented guidance in performing this task.