Target group: Future Validation Engineers and Compliance Officers. Objective: Explain the principles of validation and GxP compliance of computerized systems, and create hands-on experience for the activities to be executed. After completion of the course the participants will be able to execute validation and compliance activities on their own. Duration: every Friday for a period of 5 consecutive weeks. Description: Extended course on validation and GxP compliance of computerized systems. The course is based on GAMP 5 and the latest regulatory and industry developments. The focus is on establishing hands-on experience. This is established through a mix of theoretical introductions and workshops covering all processes to be executed during the life cycle of a system. Costs: 3000 Euro excl. VAT. |
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