Regulatory Compliance & The Role of Biomedical Outsourcing Michael Carpenito Scott Pletzer MEDICAL...
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Transcript of Regulatory Compliance & The Role of Biomedical Outsourcing Michael Carpenito Scott Pletzer MEDICAL...
Regulatory Compliance & The Regulatory Compliance & The Role of Biomedical OutsourcingRole of Biomedical Outsourcing
Michael CarpenitoMichael Carpenito
Scott PletzerScott Pletzer
MEDICAL DEVICE OUTSOURCING SOLUTIONS
2006 CARZER Technologies, LLC All Rights Reserved
Who is CARZER?Who is CARZER?
CARZER Technologies has over 20 CARZER Technologies has over 20 years experience in the medical device years experience in the medical device industry. We provide solutions to industry. We provide solutions to organizations regulated by ISO organizations regulated by ISO standards and/or FDA regulations.standards and/or FDA regulations.
2006 CARZER Technologies, LLC All Rights Reserved
CARZER’s ServicesCARZER’s Services
• Quality management systems Quality management systems • Compliance Compliance • Training & development Training & development • Contract engineering & Contract engineering &
manufacturingmanufacturing• Regulatory preparation & Regulatory preparation &
submissionsubmission• Supply base managementSupply base management
2006 CARZER Technologies, LLC All Rights Reserved
Outsourcing Reaches the Outsourcing Reaches the Entire Biomedical IndustryEntire Biomedical Industry
• AcademiaAcademia• EntrepreneursEntrepreneurs• Biomedical organizationsBiomedical organizations• Funding organizationsFunding organizations• Legal counselLegal counsel
2006 CARZER Technologies, LLC All Rights Reserved
Factors Driving OutsourcingFactors Driving Outsourcing
• Cost effectivenessCost effectiveness• ResourcesResources• Speed to marketSpeed to market• ExpertiseExpertise• Competitive edgeCompetitive edge
2006 CARZER Technologies, LLC All Rights Reserved
Today’s OutsourcingToday’s Outsourcing
……It’s about systems and infrastructure, It’s about systems and infrastructure, training and awareness, design houses training and awareness, design houses for prototyping, contract manufacturing, for prototyping, contract manufacturing, third party testing and clinical services, third party testing and clinical services, regulatory representation, experienced regulatory representation, experienced and skilled personnel, without permanent and skilled personnel, without permanent salaries. It’s more than consulting as we salaries. It’s more than consulting as we know it…know it…
2006 CARZER Technologies, LLC All Rights Reserved
Outsourcing RelationshipsOutsourcing Relationships
PreferredOutsource
EstablishedPartnership
StrategicAlliance
InitialContact
2006 CARZER Technologies, LLC All Rights Reserved
Achieving Outsourcing Achieving Outsourcing SuccessSuccess
• Begin earlyBegin early• Due diligenceDue diligence• Common objectivesCommon objectives• CommunicateCommunicate• Trust and respectTrust and respect
2006 CARZER Technologies, LLC All Rights Reserved
Regulatory ComplianceRegulatory ComplianceFDA & ISOFDA & ISO
2006 CARZER Technologies, LLC All Rights Reserved
Infrastructure to Ensure Infrastructure to Ensure Regulatory ComplianceRegulatory Compliance
• Quality management systemQuality management system• Training & awarenessTraining & awareness• Management commitmentManagement commitment
2006 CARZER Technologies, LLC All Rights Reserved
Balancing Technology & Balancing Technology & InfrastructureInfrastructure
• Technology drives an Technology drives an organization, but infrastructure organization, but infrastructure keeps it running smoothlykeeps it running smoothly
• Focus on the technology with the Focus on the technology with the right balance of infrastructure, or right balance of infrastructure, or the technology will erodethe technology will erode
• Strategic infrastructure is key, Strategic infrastructure is key, too much becomes ineffectivetoo much becomes ineffective
2006 CARZER Technologies, LLC All Rights Reserved
The Cost of ComplianceThe Cost of Compliance
• Compliance has Compliance has a pricea price
• Non-compliance Non-compliance has a much has a much greater pricegreater price
2006 CARZER Technologies, LLC All Rights Reserved
QuestionsQuestions
MEDICAL DEVICE OUTSOURCING SOLUTIONS