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Design Verification, Validation and Testing for Medical PowerPoint Presentation
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Design Verification, Validation and Testing for Medical

Design Verification, Validation and Testing for Medical

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Design Verification, Validation and Testing for Medical

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  1. ContactUs:416-915-4458 WeEmpower,YouComply! DesignVerification,ValidationandTesting for Medical Devices ProductId MD1091 Category MedicalDevices ScheduledOn Friday,June13,2014at13:00Hrs Duration 75Minutes Speaker MeenaChettiar Toregisterforthiswebinarpleasevisitourwebsitewww.compliancetrainings.com Webinar Description: DesignControlisanintegralpartofanyqualitysysteminregulatedindustries.FDAQualitySystemregulation,Quality SystemInspectionTechniques(QSRandQSIT)andISO13485havespecificproductverificationandvalidation requirementsthatmustbefulfilledinthemedicaldeviceindustry.FDAisgettingmoreandmorestringentaboutproduct designrequirementsforriskmanagementandtofulfillitsmandateforsafetyandefficacyofallmedicaldevices.The designcontrolsarenowbeingexpectedfrom outsideequipmentmanufacturers(OEM)andsupplierstothemedical deviceindustry.Thiswebinarwilleducateyouonthekeyareasthatyouneedtofocusontofulfillthedesigncontrol requirementsforyourmedicaldevice. Areas Covered in the Session: Productdevelopmentprocessoverview Applicabledesignverificationandvalidationrequirements TestingrequirementsincludingthepertinentISOguidelines Translationofuserrequirementsintodesigninputsandroleoftestingandregulatoryrequirements Fulfillingcriticaltocustomerandcriticaltoqualityrequirements Designverificationanddesignvalidationactivitycycles Traceabilityandriskmanagementatallstages DesignoutputsanddocumentationinDMR(DeviceMasterRecords)andDHR(DeviceHistoryRecords) Testrequirementstofulfilacceptancecriteriaforfinalproducts Howtowithstandregulatoryscrutiny Howarechangesandtheireffectscontrolledanddocumentedduringthedevicelifecycle? Summary             Who Will Benefit: Seniormanagement Middlemanagement Research&Development QualityEngineers ManufacturingEngineers RegulatoryAffairsProfessionals      

  2. QualityAssurance&QualityControlPersonnel DeviceDesignTeamDevice DevelopmentTeamDevice ManufacturingTeam Verificationand/orValidationplanning,executionanddocumentationfordevices. StartupCompanyLeaders       Toregisterourwebinarvisitourwebsitewww.compliancetrainings.com SpeakerProfile: MeenaChettiarisacertifiedinstructorforASQlearninginstituteforCBAandanadjunctinstructorforMedicalTechnology QualitygraduateprogramforSt.CloudStateUniversityinMinnesota.Meenaisa coauthoroftheCBA(Certified BiomedicalAuditor)PrimerfortheQualityCouncilofIndiana. SheisSeniorSupplierQualityEngineeratCovidieninPlymouth,Minnesota,USA.Priortothisposition,Meenaservedas aSeniorQualityAssociate(LeadAuditorandCAPACoordinator)atBaxterBioSurgeryinSt.Paul,MN.Meenaworkedas aSeniorQualityManageratTevaPharmaceuticalsforover10yearsandasInstrumentationlabsupervisoratLandO' Lakes.MeenahasalsoworkedforAgricultureandHealthCanadainseveraltechnicalcapacitiesforabout10years. Meena madethetransitiontothemedicaldeviceindustryaftercompletinga MSinRegulatoryAffairsforMedicalDevices throughSt.CloudStateUniversityin2010. Meenahasplayedakeyroleinqualitysystemimplementationsinthefood,pharma,andmedicaldeviceindustries. Meenahasparticipatedas theleadsupplier/internal/GMPauditorinseveralcomplianceauditsintheUSandabroad.She hasastrongauditingbackgroundinthepharmaceuticalandmedicaldeviceauditing.MeenaisaseniormemberofASQ (AmericanSocietyforQuality)andisASQcertifiedCQA(CertifiedQualityAuditor),CBA(CertifiedBiomedicalAuditor), CQIA(CertifiedQualityImprovementAssociate),andCMQ/OE(CertifiedManagerofQuality/OrganizationalExcellence). ShehasservedasaninstructorfortheseASQcertificationclassessince2006. Ms.Chettiarreceivedher M.S.inChemicalengineeringfrom UniversityofBritishColumbiaandher B.S.andM.Sin AppliedChemistryfrom theUniversityofMadras,India.MeenaisveryhappytopresentwebinarsforCompliance Trainingsandcontinuetocontributetowardsqualityandglobalregulatorycomplianceforregulatedindustries