Speaker: Carolyn TroianoKey Take AwayLearning FDA’s 21 CFR Part 11 compliance guidance on electronic records/electronic signatures (ER/ES) for computer systems is critical in developing the appropriate validation strategy for achieving the thoroughness required to prove that a system does what it purports to do, from conception through retirement.OverviewThis webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 compliance guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations.  Why Should You AttendYou should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations that uses ER/ES capability, or if you are maintaining or supporting such a system. Areas Covered In This WebinarGain an understanding of FDA’s 21 CFR Part 11 guidance document for electronic medical records trainingDevelop the ability to apply 21 CFR Part 11 when implementing, and maintaining computer system validation in your organizationUnderstand the best practices for maintaining a computer system with ER/ES capability in a validated stateDiscuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriatelyLearn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capabilityUnderstand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated stateLearn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge Learning ObjectivesGet an understanding of how to adhere to 21 CFR Part 11 guidelines when planning, executing and maintaining computer system validation Develop a sound strategy for meeting FDA complianceUnderstand the level of effort required for executing each phase of the System Development Life Cycle methodology, as it pertains to ER/ES capabilityThe appropriate level of documentation that must be completed to support it  Gain an understanding of the training and skills required to apply 21 CFR Part 11 to systems when validating or maintaining themLeverage these practices across all systems by creating a standardized program for applying 21 CFR Part 11 guidelines to systems in accordance with FDA requirements Who Will BenefitInformation Technology AnalystsQC/QA Managers and AnalystsClinical Data Managers and ScientistsAnalytical ChemistsCompliance ManagersLab ManagersAutomation AnalystsComputer System Validation SpecialistsGMP Training SpecialistsBusiness Stakeholders ConsultantsLevelIntermediate