Ⅰ．BenefitsofthetrainingIntroducethenewestregulationandstandardrequirementsinqualitymanagementprocessofsterilitytestingPresentdifferentkindsofmethodsofsterilitytestingindetailinordertoimprovethequalitymanagementlevelandefficiencyinthefieldofmedicaldevice.inthetraining,itincludescasestudy,analyzinganddiscussingsothatitcanbeefficient.Ⅱ.Trainingobjects:Staffwhoareengagedinproductionsupervision,routinecontrolandinspectioninmedicaldeviceregulator.Staffwhotakepartinproductionmanagement,qualityassurance,qualitycontrolandtestinginmedicaldeviceenterprises.PeoplewhowanttoknowrelevantskillsⅢ．TrainingcontentChoice,usageandmaintenanceofha***arewhichisneededbyRoutinemicrobiologicaltest.TypesofmediumandtheirchoiceandusageThechoiceofsamplepreparationandapplicationThechoiceandconfirmationofexperimentalmethodThetransfertechnologyofmicroorgani***andcultivatemicroorgani***ssystemObservationmethodsoftrainingresultsTestingresultreco***andbasiccontentofthetestingreportExperimentqualitycontrolTheinitialpollutionbacteriainspectionPyretogenictestingPurewatertestingsterilitytestingphysicaloperationⅣ．Trainingtimeandplace:Time:September2012Place:Guangzhou,Ⅴ．IntroductionoforganizersGuangdongMedicalDeviceQualitySupervisionandTestInstituteGuangdongMedicalDeviceQualitySupervisionandTestInstitutewasfoundedin1988,directlyaffiliatedinstitutionofFoodandDrugAdministration,theonlynationalmedicalequipmentinspectioninstitutioninsouthernChinaaswellasthemedicaldeviceequipmentqualitysupervisionandinspectionlaboratorywhichisappointedbytheStateFoodandDrugAdministration.ItperformsthedutiesofGuangdongprovincequalitysupervisionandmedicalequipmenttestingstati***andGuangdongmedicinepackingproductqualitysupervisionandinspectionoffices.Itisalsoresp***ibleforthequalitysupervisionandinspectioninthestate,provincesanddistricts,atthesametime,itisthenationalcompulsoryCCCcertificationofproductsdesignatedtestinglaboratoryandinspectionlaboratoryofCEauthenticationproductsauthorizedbyGermanyTUVPSMedicalDeviceQualityManagementCommittee,ChinaQualityAssociationforPharmaceuticalsMedicalDeviceQualityManagementCommittee,ChinaQualityAssociationforPharmaceuticalsisacommonwealsocialorganizationwhichisregisteredbyMinistryofCivilAffairs.Astheassistantofdevelopingmedicaldevicequalitymanagement,itisascienceandtechnologyorganizationwhichistakenpartinbypeoplewhofocusonthemanagementofmedicaldevice,aswellastohelpgovernmentcontactwithpharmaceuticalenterprises.ItisundertakenbyChinaQualityAssociationforPharmaceuticalsanditisaffiliatedtoGuangdongMedicalDeviceQualitySupervisionandTestInstitute.O***undaMedicalDeviceC***ultingOrganizationO***undaMedicalDeviceC***ultingOrganizationwhichfocusesonprofessionalc***ultinginthefieldofmedicaldevice,foundedin2004,hassetupsevenwhollyownedsubsidiariesinGuangzhou,Beijing,Shanghai,Suzhou,Shenzhen,JinanandAmerica.Weareabletoprovidefullysoluti***tomedicaldevicemanufacturers,includingmarketingresearch,technicalandcapitalservices,workshopselectionanddesign,clinicaltrail,qualitysystemestablishment,thirdpartyauditandglobalmarketingapproval.ThetrainingcertificateisissuedsolelybyGuangdongMedicalDeviceQualitySupervisionandTestInstitute,MedicalDeviceQualityManagementCommittee,ChinaQualityAssociationforPharmaceuticalsandO***undaMedicalDeviceC***ultingOrganization.)