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Computer Validation: Introduction to Risk Management & Maintaining the Validated State
15-17 October 2008
Prague, Czech Republic
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At this conference we offer a Conference Exhibition.
Please click here in order to view the registration form (PDF) for exhibitors.
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Computer Validation: Introduction to Risk Management
15 October 2008, Prague, Czech Republic
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.
Computer Validation: Maintaining the Validated State
16-17 October 2008, Prague, Czech Republic
Learning Goals
3 good reasons why you should attend:
You will get to know methods for maintaining the validated state of a computerised system in a GMP-compliant 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.
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.
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