Description :We will discuss the importance of applying industry best practices when managing projects involving development, configuration, implementation, testing, validation and other System Development Life Cycle (SDLC) phases for any IT system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly.This course will describe the best practices for managing such a project, including “who" should be responsible for tasks, "how" the documentation should be accomplished, and “what” specific criteria will be used to define success. FDA guidelines are very specific in terms of how this is to be done.Areas Covered in the Session :Project planning, execution and management conceptsGxP Predicate RulesComputer System Validation (CSV)System Development Life Cycle (SDLC)Risk-based approach to validationGAMP V approach to system categorization and validationImplementation and validation of systems in compliance with FDARoles, responsibilities and trainingDocumentation required for FDA complianceMaintaining a system in a validated stateRatio of system cost to compliance with FDASOPs required for supporting a validated systemIndustry Best PracticesInteractive Q&AWho Will Benefit:who will benefit from this webinar include:Information Technology AnalystsInformation Technology Developers and TestersQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsCompliance and Audit ManagersLaboratory ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders/Subject Matter ExpertsBusiness System/Application Testers