Description :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.For easy implementation, attendees will receiveSOP: Validation of Commercial Off-the-Shelf Computer SystemsSOP: Development and Maintenance of Test Scripts for Software and Computer SystemsChecklist: Using computers in FDA regulated environmentsAreas 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?Example for IQ protocolsOQ test protocols: development, execution, approval - examplesDocumentation of ongoing performanceValidation of existing systemsStructure and example of a validation reportStep-by-step case studies from laboratories and manufacturing for easy implementationWho Will Benefit:A must attend webinar for professionals in Pharmaceutical and medical device industry, Manufacturers of pharmaceutical ingredients and Contract manufacturers and laboratories. The teams that will benefit the most are:IT managers and system administratorsQA managers and personnelQC Lab managers and üersonnelValidation specialistsRegulatory affairsTraining departmentsDocumentation departmentConsultants