美国FDA验证高级培训-药智论坛

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1、美国FDA验证高级培训DenisKluba博士吴培栋博士如果想要下载更多的资源请百度一下药智论坛目录TableOfContents验证定义CGMP对验证的要求验证历史与期望验证综述验证主方案与规划实施验证的方法验证的技术内容要求执行验证方案工作流程改变控制再验证总结如果想要下载更多的资源请百度一下药智论坛PartOne:WhatisValidation??第一部分：验证定义如果想要下载更多的资源请百度一下药智论坛WhatisValidation?ForthisSeminaritreferstotwothing

2、s:1.TheUSAFDArequirementsthatmustbemetinordertosuccessfullyandcontinuallyselldrugproductsintheUSA2.Activitiesthatwillcontributetothesuccessofthecompanyinthemanufactureofdrugproducts验证的含义？如果想要下载更多的资源请百度一下药智论坛Validation“Anythingwhichyoucannotunderstandisindis

3、tinguishablefrommagic.”ArthurC.Clark“Validationmaynotbemagic!”C.Edwards业内对验证的理解如果想要下载更多的资源请百度一下药智论坛ValidationIs.....“Documentedevidencewhichprovidesahighdegreeofassurancethataspecificprocesswillconsistentlyproduceaproductmeetingitspredeterminedspecification

4、sandqualityattributes.”FDA对验证的定义如果想要下载更多的资源请百度一下药智论坛ToConsistentlyProduceADesiredKnownProductWhyDoWeValidate?ConfirmDesignEstablishOperatingBoundariesEstablishBaselinesProductComplianceTestwithinSpecification验证的作用/目的如果想要下载更多的资源请百度一下药智论坛HowDoWeValidate?Detai

5、lsWillFollowButThisistheGeneralModelIdentifyEquipmentSystemsDevelopTestsWriteProtocolsConductTestsEvaluateDataReportResultsResultsOK?yesNoAmendProtocolAmendTestCollectDataValidatedSystemSystemModified?验证流程图如果想要下载更多的资源请百度一下药智论坛FirstthreestepstoCGMPcompliance

6、documentdocumentdocument符合CGMP要求的头三步如果想要下载更多的资源请百度一下药智论坛BoundariesofValidationEngineeringCOMMISSIONINGSTART-UPTROUBLESHOOTINGTRIALRUNSCYCLEDEVELOPMENTPROCESSDEVELOPMENTENGINEERINGSTUDIESVENDORSERVICEREPORTSFACTORYACCEPTANCETEST“AS-BUILT”DRAWINGSSTANDARDOPER

7、ATINGPROCEDURESMFGBATCHRECORDSPERSONNELTRAININGCALIBRATIONPREVENTATIVEMTCECHANGECONTROLCOMPLIANCEVENDORAUDITSANNUALREVIEWSCOMPLAINTSSAFETYOperations/QAValidationDOCUMENTEDPROGRAMHIGHDEGREEOFASSURANCECONSISTENTLYMEETSPREDETERMINEDSPECIFICATIONS验证的界限/范围如果想要下载

8、更多的资源请百度一下药智论坛ValidationLifeCycleApproachProspective/ConcurrentDefineSpecificationsEquipmentProcessRequirementsProceduresDesign/SpecifyEquipmentDefineProcessDevelopProcedureSpec.InstallEquipmentVerifyP