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Design Verification, Validation and Testing for Medical

Design Control is an integral part of any quality system in regulated industries. FDA Quality System regulation, Quality System Inspection Techniques (QSR and QSIT) and ISO 13485 have specific product verification and validation requirements that must be fulfilled in the medical device industry. FDA is getting more and more stringent about product design requirements for risk management and to fulfill its mandate for safety and efficacy of all medical devices. The design controls are now being expected from outside equipment manufacturers (OEM) and suppliers to the medical device industry. This webinar will educate you on the key areas that you need to focus on to fulfill the design control requirements for your medical device.

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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

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