cmo quality oversight & risk management, april 2011, boston
DESCRIPTION
Managing CMOs to Deliver Your Product to Your Quality & Time RequirementTRANSCRIPT
Featured Presentations:
April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA
CMo Quality oversight & risk ManageMent
Managing CMOs to Deliver Your Product to Your Quality & Time Requirements
dhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS
rhonda Fendelet, Director, External Supply Integration Quality – PDMS, JANSSEN SUPPLY CHAIN
rolf hartmann, Procurement Director, GLAXOSMITHKLINE
Juanita hawkins, Vice President, Global Quality Assurance and Compliance, CELGENE
Jeff huth, Ph.d., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT
denise Mcdade, Senior Director, Quality Assurance, AMYLIN PHARMACEUTICALS
robert o’hagan, Director Quality Operations,ABBOTT BIORESEARCH CENTER
Caroline o’Brien, Associate Director QA Sourcing, Pharmaceutical Development, ASTRAZENECA
sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS
Prashant savle, Ph.d., Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME
Michael semo, Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY
g. sean Williams C.P.M., sCor-P,Associate Dir, Global Facilities Procurement, BRISTOL-MYERS SQUIBB
Janice B Wilson, Phd, Vice President Corporate Quality Assurance, ELAN PHARMACEUTICALS
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regulatory Perspective on Quality assurance within the evolving Contract Manufacturing relationship sandra roque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS
applying a risk Management system to the Contracting Process to sustain the highest level of Quality from a CMo/sponsor relationshipCaroline o’Brien, Associate Director QA Sourcing, PharmaceuticalDevelopment, ASTRAZENECA
how overall Product lifecycle and Product Phases including Commercialization Can Factor into the Contract Manufacturing relationship Jeff huth, Ph.d., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT
Featured Panel disCussion:
global Considerations and Business differences when Contracting an off-shore CMo Partner: how Close are We to a harmonized standard of gMP?Panelists:
Prashant savle, Ph.d., Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME
Michael semo, Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY
dhan amaria, Director, Quality Assurance, NEKTAR THERAPEUTICS
sPeaking FaCulty
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Dear Colleague,There is industry agreement that a substantial investment must be made to
support the life-cycle of a pharmaceutical product from the developmental stage
to commercial production. There is also definitive data that shows in addition to
the FDA, regulatory bodies worldwide are becoming more and more conservative
with the candidates they approve for commercial access.
Within the contract manufacturing relationship, pharmaceutical companies are
taking the necessary steps to adjust to this changing industry trend, providing
increased resources to ensure control and consistency in the manufacturing of
their products to avoid unnecessary delays including regulatory action.
Join us April 28th - 29th where presentations dedicated to the successful CMO
partnership dynamic will be shared, including best practices in management such
as quality oversight, risk management, and ensuring time requirements are met.
The FDA has made it clear that if your name is on the label, you are responsible
for what’s inside the package.
Look forward to seeing you in Boston!
Sincerely,
Matthew MillmanSenior Conference [email protected]
OmNI PARkER HOuSE HOTEl
60 School StreetBoston, MA 02108
P:617-227-8600
As you pass through the sculpted bronze doors of this luxury Boston hotel, you will be enveloped by the timeless beauty that has made the Omni Parker House a landmark since 1855. Experience the perfect blend of modern amenities and historic charm at America’s oldest continuously-operating hotel. Walk to Beacon Hill, Faneuil Hall Marketplace, Quincy Market, the Financial District, shopping and more. Just 2.5 miles (10-15 minutes) from Logan International Airport.
room reservations: If you require overnight accommodations, please contact the hotel and state that you are with ExL’s CMO Quality Oversight & Risk Management Conference for information on our discounted room rates. We encourage conference participants to make reservations by Wednesday, April 6th with our designated venue as our discounted room rates are limited.
Sponsorship and Exhibit Opportunities
Do you want to spread the word about your organization’s solutions and services to potential clients who attend this event? Take advantage of the opportunity to exhibit, present an educational session, host a networking event, or distribute promotional items to attendees. ExL works closely with you to customize a package that suits all of your needs.
To learn more about these opportunities, contact Eric Morrin, Business Development Manager by calling 212-400-6228 or by emailing
This Summit is specifically designed for C-Levels, Department Heads, Vice Presidents, Directors and Managers at pharmaceutical, biotechnology and medical device companies from the following
departments:
Contract manufacturing
manufacturing Operations
Regulatory Affairs
Regulatory Compliance
Validation
Compliance
Quality Assurance
Quality Operations
Quality Development
Outsourcing
Sourcing
Supply Chain
Operational Excellence
To Regis ter Cal l 866-207-6528 or v is i t www.exlpharma.com/cmo
Pre-ConFerenCe WorkshoP
To Regis ter Cal l 866-207-6528 or v is i t www.exlpharma.com/cmo
day one – aPril 28th, 2011
8:00 Registration Opens and Continental Breakfast is Served for Workshop Attendees
9:00 selecting a CMo Partner
HowIncludingQualityEarlyintheSelectionProcesscanEnsurea StrongerOverallPartnership Led By: JaniceBWilson,PhD,Vice President Corporate Quality Assurance, ELAN PHARMACEUTICALS
• Includingqualityintheselectionprocess -Transparencyandaccessibilityofapotentialpartners’qualityhistory -Whatqualityfactorstolookforfromapartner -Whatissuescankillthedeal?
• Designingqualityagreementswithclearcriteriathatdefinetheresponsibilitiesofanoutsourcedpartner-IdentifyingtheimportantdeliverablesthatneedtobeincludedintheQualityAgreement-CustomizingaQualityAgreementthatfitsaspecificprojectaspect-Determiningwhichtypesofagreementstouse–technicalversusquality?Whatisthedifference?-ModifyingaQualityAgreementtoreflectexistingregulationsandindustrystandards
*There will be a 30-minute coffee and networking break during the workshop
12:00 Lunch for Workshop Attendees / Registration Opens for Main Conference
Main ConFerenCe
1:15 Chairperson’s Welcome and Opening Remarks
1:30 keynote talk: CMo ManageMent strategy
AligningYourCorporatePhilosophyandYourCMOOutsourcing StrategytoAchieveBusinessObjectives JuanitaHawkins, Vice President, Global Quality Assurance and Compliance, CELGENE
• Gaininginternalbuy-inandunderstandingtheriskrelatedtostrategy• Criticaldecisionmakingforinternal,externalorhybridmanufacturingallocation• Clarityforexpectations,delegatingworkversusresponsibility,andcontrol
2:15 regulatory Perspective
RegulatoryPerspectiveonQualityAssurancewithinthe EvolvingContractManufacturingRelationship SandraRoque, Director, Manufacturing QA, NOVEN PHARMACEUTICALS
• Agencyconcernsoverbusinessprocedures• ExpectationsforbothsponsorsandcontractsitesduringinspectionsandGMP
assessments• Bestpracticestoensurethatsponsors,contractmanufacturersandregulatory
agenciesareallonthesamepage• Upcominganticipatedguidanceforselectionofacontractfacilityand
conductingaudits
3:00 networking & refreshment Break
3:30 Case study: integrated Facilities Management outsourcing
ThinkingwiththeEndinMind:DrivingaStreamlinedGlobal IntegratedFacilitiesManagementOutsourcingDealfromConcept toImplementation G.SeanWilliamsC.P.M.,SCOR-PAssociateDir,GlobalFacilities Procurement,BRISTOL-MYERSSQUIBB
• EvaluatingtheprosandconstounderstandwhetheranIFMprogramfitsintoyourcompany’sstrategicplanning
• Buildingtheappropriatequalityandperformancemeasurementsinthenegotiationtopreventpostimplementationmarginerosion
• KeydriversofServiceProviderdownselectingoutsideofcost
4:15 Communication TheRoadmapforSuccessfulCommunicationwithinaPartnershipthat DrivesQualityOversightSuccess RhondaFendelet, Director, External Supply Integration Quality – PDMS, JANSSEN SUPPLY CHAIN
• ThegovernancemodelanddeploymentofCommunicationPlan• Clarifyingroles&responsibilitieswithintherelationshiptoavoiddysfunction• Usingmetricsandfeedbackasthekeyperformanceindicatorsforsuccess
5:00 Close of day one
Main ConFerenCe
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day tWo – aPril 29th, 2011
9:00 Chairperson’s Day Two Welcome and Opening Remarks
9:05 lifecycle Considerations
HowOverallProductLifecycleandProductPhasesIncluding CommercializationCanFactorintotheContractManufacturing Relationship JeffHuth,Ph.D., Leader, Quality & Compliance, JANSSEN ALZHEIMER IMMUNOTHERAPY RESEARCH & DEVELOPMENT
Contract Manufacturing Organizations face an evolutionary dilemma in trying to establish their business plan strategy and technical capabilities every day. While clearly there is a capital investment consideration in this regard, there are also key technical, operational, and regulatory considerations. ThisSessionwillExamine:• Elementsassociatedwithpharmaceuticalproductlife-cycleastheyrelatetothe
technical,operational,andregulatoryissues• Discussiononthesignificanceofthepartnershipsrequiredtosuccessfullymanage
theevolutionarypharmaceuticalproductlife-cycle• HowICHguidanceconcepts(inparticular,ICHQ10)canprovideaplatformtonot
onlymanagetherelationship,buttoenhanceit.
9:45 risk Management ApplyingaRiskManagementSystemtoVendorAssuranceandSupplier ManagementinDevelopment CarolineO’Brien, Associate Director QA Sourcing, Pharmaceutical Development, ASTRAZENECA
• Clearlyandthoroughlytranslatingriskfactorsformaterials,processesandsuppliers• UnderstandingofSupplyChainandapplicationofriskmanagedsupplierauditing• DevelopmentandmaintenanceoftheholisticapproachtoSupplierManagement
10:30 networking & refreshment Break
11:00 spotlight session: outsourcing and Quality in latin america ConsiderationswhenContractingaCMOPartnerinLatinAmerica: RegionalBenefits&Constraints RolfHartmann,Procurement Director, GLAXOSMITHKLINE
• ExaminingcostdifferencesbetweenCMOsinLatinAmericaandotherRegions• Ensuringqualitystandardsandregulatoryrequirementsaremetandkeptwhen
workingwithaninternationalCMO• LatinAmericaregionalsnap-shot:contractingintraditionalversus
non-traditionalcountries
11:45 international Considerations PANELDISCUSSION:GlobalConsiderationsandBusinessDifferences whenContractinganOff-ShoreCMOPartner:HowCloseareWeto aHarmonizedStandardofGMP? Panelists Include: DhanAmaria,Director, Quality Assurance, NEKTAR THERAPEUTICS PrashantSSavle,Ph.D.,Director, Sourcing, Global Procurement, MERCK SHARPE & DOHME MichaelSemo,Global Sourcing Manager, Virtual CMC Team, ELI LILLY & COMPANY
• Whatarethedifferencesbetweenadomesticpartnerandaninternationalone,ifany?
• Whatculturalconsiderationsshouldbemadepriortocommencementofthepartnershipandhowdotheseaffectthelevelofcommunicationandexpectations?
• Howdoesriskacceptabilityvarybetweenasponsorandacontractpartner?
12:30 lunch
1:30 Metrics UsingKPIsandOperationalExcellencetoEnsureQualityinan OutsourcedSupplyChain DeniseMcDade, Senior Director, Quality Assurance, AMYLIN PHARMACEUTICALS
• Settingqualityoversightstandardsthatdrivethelevelofperformancemeasurementanddatacollection
• Buildingacorporateculturethatcancreateastrategytomeetthestandardsnecessaryforqualityexcellence
• Adoptingrisk-sharedprinciplesthatextendaccountabilitytoaproject-widescope
2:15 aPi development KeysforSuccessfulContractManufacturingofBiologicalAPI’sto SupportClinicalandCommercialMaterial RobertO’Hagan, Director Quality Operations, ABBOTT BIORESEARCH CENTER
• CMOSelectionConsiderations• SuccessfulBusinessModelforCMOthroughproductlifecycle• QualityAgreementsandRegulatoryConsiderations
3:00 Closing Panel disCussion: Decommissions,FacingProblems,andAcceptingthatthePartnership isFaulty–WhatShouldbeDonetoMinimizetheFailure FeaturingConferencePresenters
• Whataretheinitialstepstobetakenonceapartnershipisdisconnected?• Howtocalculatethefinancialimplicationsfromthemisstepsthathaveoccurred?• Determinewhattheconsequencesareandiftheycanbefixed?• Whatarethepublicandreputationaldamagethathasbeendone?
3:45 Close of Conference
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risk ManageMent ConFeRenCe:
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save 25% Per Person When registering Four For every three simultaneous registrations from your company, you will receive a fourth complimentary registration to the program (must register 4 at one time). this is a savings of 25% per person.
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QuESTIONS? COmmENTS?do you have a question or comments that you would like to be addressed at this event? Would you like to get involved as a speaker or discussion leader?
Please email Conference director, Matt Millman at [email protected]
Regulatory Perspective on Quality Assurance within the Evolving Contract manufacturing Relationship
Applying a Risk management System to the Contracting Process to Sustain the Highest level of Quality from a CmO/Sponsor Relationship
How Overall Product lifecycle and Product Phases Including Commercialization Can factor into the Contract manufacturing Relationship
Global Considerations and Business Differences when Contracting an Off-Shore CmO Partner: How Close are we to a Harmonized Standard of GmP?
CMo Quality oversight & risk ManageMent
Managing CMOs to Deliver Your Product to Your Quality & Time Requirements
To Register Call 866-207-6528 or visit www.exlpharma.com/cmo
Featured Presentations:
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888-221-6750
www.exlpharma.com/cmo
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sPeaking FaCultyFroM these CoMPanies
NEKTAR THERAPEUTICS
MERCK
GLAXOSMITHKLINE
CELGENE
ASTRAZENECA
NOVEN PHARMACEUTICALS
ELI LILLY & COMPANY
BRISTOL-MYERS SQUIBB
ELAN PHARMACEUTICALS
REGISTER BY FeBruary 25
AND SAVE $400!
April 28th – 29th, 2011, Omni Parker House Hotel, Boston MA