Overview: The validation of computer system has been an FDA requirement since more than 20 years. Nevertheless companies have problems with implementation. This is proven through many FDA warning letters related to software and computer system validation, especially in the last three years. Validation professionals know the principles but have problems with implementation, especially with the development of protocols. This seminar will give a good understanding of FDA requirements for computer system validation and provide steps for cost-effective implementation.Reference material for easy implementation:SOPs: Validation of Commercial Off-the-Shelf Computer SystemsChecklist: Using computers in FDA regulated environmentsValidation examples from planning to reportingAreas Covered in the Session:US FDA and EU requirements and enforcement practicesLearning from recent FDA 483's and warning lettersSelecting the right validation model: qualification vs. verificationEight fundamental steps for computer system validationStructure and example of a validation planJustification and documentation of risk levelsExample qualification document for suppliers of commercial systemsExamples for requirement and functional specifications?Who Will Benefit:IT Managers and System AdministratorsQA Managers and PersonnelQC and Lab ManagersValidation SpecialistsRegulatory AffairsTraining DepartmentsDocumentation DepartmentConsultantsLudwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. GlobalCompliancePanel Phone: 800-447-9407Fax: 302-288-6884