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1、FUNDAMENTALSANDESSENTIALSOFVALIDATION验证基础及实质MichaelAnisfeld（Dr.麦克.安斯菲尔得）GlobepharmConsulting1©CopyrightGlobepharm,2005课程安排COURSESCHEDULEINTRODUCTION+REGULATORYENVIRONMENT介绍＋法规环境VALIDATIONBASICS验证基础知识VALIDATIONMASTERPLANS验证主文件PROCESSVALIDATION工艺验证UTILITIESVALIDATIO
2、N公用系统验证CLEANINGVALIDATION清洁验证COMPUTERVALIDATION计算机系统验证ANALYTICALMETHODVALIDATION分析方法验证CASESTUDY案例研究2©CopyrightGlobepharm,2005HousekeepingCourseNotes课程注意MasterListSurveysAreYouLost?English–American?MobilePhone–Beepers-PagersRestroomsFireDrillBreaksandEndingMessages
3、fromOfficeAirport?3©CopyrightGlobepharm,2005培训期间DuringthisTrainingSessionIf如果:1.Igotoofast我讲的太快2.Iusestrangewords我使用陌生词语3.Igettootechnical我讲的太专业PleaseInterruptandAsk….ThereIsNoSuchThingAsASillyQuestion请随时打断我，并提问。。。。4©CopyrightGlobepharm,2005请大家自我介绍WHOAREYOU?TellUs
4、YourNAME告诉我你的名字TellUsYourCOMPANY告诉我你的公司TellUsYourJOB你的职务TellUsThePRODUCTSYOURCOMPANYMAKES你公司生产的产品TellUsYourEXPERIENCEWITHVALIDATION有关验证的经验TellUsWhatSPECIFICALLYYOUCAMETOLEARN你想了解的内容5©CopyrightGlobepharm,2005Dr.麦克.H.安斯菲尔得MICHAELH.ANISFELDIndustrialPharmacist执业约师Ind
5、ustrialPharmacyFaculty–UniversityofIllinois毕业于伊利诺伊州州立大学药学系HastrainedFDAandMCAinspectors培训过FDA＆MCA检查官PerformauditsonbehalfofUNagenciesandgovernments代表联合国＆政府部门进行审计Performs25–35fullscaleauditsannually每年进行25－35个审计Hasauditedin32countries对32个国家的医药企业进行过审计Guidesclientsthr
6、oughFDA,MCA,TGA,HPFBIandotherinspections帮助客户通过FDA,MCA,TGA,HPFBI及其他官方机构的现场检查6©CopyrightGlobepharm,20057©CopyrightGlobepharm,2005验证VALIDATIONDefinitionVery非常定义辛苦ArduousLengthy周期长Involvedand棘手Detailed详细的Attemptto试图要Test测试Everything所有事务8©CopyrightGlobepharm,2005验证原理及要
7、素FUNDAMENTALSANDESSENTIALSOFVALIDATIONSREGULATORYENVIRONMENT法规环境9©CopyrightGlobepharm,2005质量QUALITY“acomprehensivesystem,designed,documented,implementedandcontrolled,furnishedwithpersonnel,equipmentandresources,toprovideassurancethatproductswillbeconsistentlyfitfo
8、r,andappropriateto,theintendeduse”一个全面的质量体系，包含了设计，文件，执行，控制，以及提供足够的人员、仪器、资源，为了确保产品能持续达到既定目标。10©CopyrightGlobepharm,2005工艺验证PROCESSVALIDATION[FDA]“establi
