Description :You should attend this seminar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system.Effective and compliant computer system validation is critical to any pharmaceutical or FDA-regulated organization. During the past 30 years, best practices that have been developed will ensure that validation activities are cost-effective while meeting all aspects of FDA compliance.There is an enormous body of documentation and information available that can be overwhelming. This course will provide a condensed overview of the practices that deliver the best results by directing the attendees to the most critical and cost-effective of methods, techniques and tools available.We will discuss the importance of classifying computer systems subject to FDA regulations in accordance with GAMP V. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do.Upon completion of this session, attendees will have an understanding of how to classify computer systems in accordance with GAMP V, and develop a sound validation strategy for each system to meet FDA compliance.Areas Covered in the Session :Gain an understanding of GAMP V computer system classificationsDevelop the ability to apply GAMP V in classifying computer systems in your organizationUnderstand the level of computer system validation required, based on the classification as determined using GAMP VDiscuss the best practices necessary to ensure all systems are classified properly and validated appropriatelyLearn how to develop the appropriate computer validation strategy, including the level of testing required for the given computer system classification, as determined by GAMP VUnderstand how to effectively document the process of computer system classification and how to maintain current information about the various systems in your organization and how they are validatedLearn how to gain information about trends in validation, as industry progresses and new best practices emergeUnderstand the level of training required for the various GAMP V computer system classifications, and the skills and expertise necessary to make the classification determinationWho Will Benefit:Information Technology AnalystsQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsCompliance ManagersLab ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness stakeholders and individuals who are responsible for CSV planning, execution, reporting, compliance, and auditConsultants