computer systems and software validation

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1、ApproachestoSatisfyProvenProactiveComputerSystemsandFDARequirements!!December5-7,2006SoftwareValidationAmsterdam,theNetherlandsAMUSTATTENDEVENTExamineSoftwareDevelopmentandBEFORETHERELEASEOFTestingResponsibility!THENEWPART11RE-WRITE!SPECIALGUESTS:TheExpectationsandObservationsofaEurope

2、anInspectorMalcolmOlver,GMPInspector,MedicinesandHealthcareproductsRegulatoryAgency(MHRA)PreparingYourOrganizationfortheNewPart11LudwigHuber,Ph.D.,ComplianceProgramManager,AgilentTechnologiesMEDIAPARTNERWEBPARTNERSLEARNESSENTIALSTEPSTOIMPLEMENTCOMPUTERSYSTEMS&SOFTWAREVALIDATIONTONEWAND

3、EXISTINGSYSTEMS!•Risk-BasedComputerSystemValidationADVANCEDTRACK•ValidationofLaboratoryDataSystems•OptimizationoftheSystemTestingProcess•WhyisthePart11rewritetakingsolong?•AuditingandPenetrationTestingNetworkspharmaceuticaltechnology.comforEnhancedComplianceThewebsiteforthepharmaceutic

4、alindustry•ContingencyPlanningandDisasterRecoveryforComputerSystems•AuthenticationandSignaturesUsingPasswords,•ChangeControlandConfigurationDigitalSignatures,andBiometricsPresentedbyManagement•InternetApplications–MakingOpenSystemsCompliantBONUS!!SAMEVENUE!SAMEDATES!FreeAccesstoIVT’sEq

5、uipmentQualification&SystemConference!SeeRegistrationpageformoredetailsComputerSystemsandSoftwareValidation•December5-7,2006EventAt-A-GlanceTUESDAY,DECEMBER5,2006WEDNESDAY,DECEMBER6,2006THURSDAY,DECEMBER7,20067:30AM–Pre-conferenceRegistrationand7:30AM–ContinentalBreakfast7:30AM–Contine

6、ntalBreakfastContinentalBreakfastMainConferencePost-ConferencePre-ConferenceHalf-DayWorkshopsC-D90-MinuteSessions1-2Half-DayWorkshopsA-B8:30AM–12:00PM8:30AM–10:00AM8:30AM–12:00PMINTERACTIVEWORKSHOPC(HUBER)INTERACTIVESESSION1(ADVANCEDTRACK)(DRAPEAU)INTERACTIVEWORKSHOPA(ANDERSON)Validati

7、onofLaboratoryDataSystemsAuditingandPenetrationTestingNetworksforRisk-BasedComputerSystemValidationEnhancedComplianceINTERACTIVEWORKSHOPDINTERACTIVEWORKSHOPB(ARAKANGAS)(ADVANCEDTRACK)(KUNIHOLM)INTERACTIVESESSION2(STOCKDALE)CostEffectiveManagementoftheCompleteLifecycleOptimizationofth