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Benchmark from Industry Experts:
Jack Chu, PE, Manager, Technical Support, Merck & Co., Inc.
Bill Dun, Regulatory and Validation Manager in China, Merck Millipore
Jeffrey R. Felker, Manager, Pharmaceutical Technology, sanofi pasteur, Inc.
Justin J. Fisher, Senior Manager, Pfizer Inc
Elaine Kelleher, Validation Lead, Merck, Sharp and Dohme
Todd Mabe, Principal Technical Manager – Validations, Roche Singapore Technical Operations Pte Ltd
Mimi Virlany Syahputri, Degree Of Pharmacist, Universitas Indonesia, Site Change Coordinator, Novartis Singapore Pharmaceutical Manufacturing
Dawn Tavalsky, Deputy Director Cleaning Validation, sanofi pasteur, Inc.
Zhang Xuexin, Bachelor (Master in Study), Engineering Manager, Novozymes (China) Biopharma Co. Ltd.
Harry Yang, Ph.D., Senior Director, MedImmune, LLC
Weifeng “Frank” Zhang, Master of Engineering, Quality Engineering, Bristol-Myers Squibb Company
28 -29 F e b r u a r y 20 12 • T h e P a n P a c i f i c H o t e l • S i n g a p o r e
r e g i s t e r o n l i n e a t w w w . c b i n e t . c o m / v a l w e e k s i n g a p o r e
Maximise your Company’s Training and Choose Between Three Information-Packed Tracks!VALIDATION
• Implement Process Validation Company-Wide
• Understand, Reduce and Control Variation
• Qualify Virtual Networks and Cloud Computing
• Streamline the Validation Process
• Equipment Qualification — Fit for Intended Use
• Identify and Qualify Critical Utilities
QUALITY SYSTEMS • Implement an Effective Change Control Program
• Utilise Key Quality Risk Management Methods and Tools
• Audit and Conduct a Gap Analysis
• Design a Corrective and Preventive Action Plan
• Prepare for and Handle Regulatory Inspections
• Ensure Product Quality through Stability Design and Analysis
ASEPTIC PROCESSING • Identify Risk in Aseptic Processing
• Control Microbiological Contamination
• Develop a Lean Cleaning Validation Program
• Establish Risk-Based Cleaning Validation Acceptance Criteria
• Organisation, Training and Process Flow for Sanitisation of an Aseptic Facility
• Common Pitfalls in Aseptic Processing and Cleaning Validation
Organised By:
Subsidiaries of:
Lead Media Partner:
R e g i s t e r b y 2 2 D e c e m b e r 2 0 1 1 a n d R e c e i v e $ 3 0 0 O f f o f Y o u r R e g i s t r a t i o n F e e !
Compliance Week IVT’s 2nd Annual Validation and cGMP
Achieve Manufacturing Excellence through Optimal Quality Practice
1 • A Case Study of Implementing Process Validation Company-Wide
I. PlanningandImplementation• Draftacharterdocument• Establishtheteamandassignroles
andresponsibilities• Conducta“voiceofthecustomer”
astotheexpectationsofallendusers• Draftanactionplananddeliverables
II. Intra-companyCollaboration• Standardisation—
Lifecycleapproachtotheuseoftemplates• Collaboration—
Understandandlistentoeachother• Globalchangemanagementsystem• Measureofsuccessandcontinuouslearnings
III. InteractiveExercise• Participantsreviewanddiscussanexample
planusedtoimplementthenewFDAguidancedocumentonprocessvalidationglobally
Elaine Kelleher, Validation Lead, Merck, Sharp and Dohme
9 : 0 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 1 - 3 )
I. Introduction• Whatischangecontrol?• Whentousechangecontrol• Whowillberesponsibleforchangecontrol?
II. Define/ImprovetheChangeControlSystem• Mapallsystems/processes• Reviewcurrentchangecontrolsystems
• System/processchangesgrouping• Setupchangecontrolsystemhierarchies• Changecategorisation(type,complexity,
importance/urgency)
III. SetUptheChangeControlSystem• Standardoperationprocedure/form• Establishguidance
IV. ImplementChangeControlSystem• Createinteractivetraining• Monitoringandcontinuousimprovement
V. BonusMaterial• Exampleofmatriximpactassessment
Mimi Virlany Syahputri, Site Change Coordinator, Novartis Singapore Pharmaceutical Manufacturing
2• Best Practices to Implement an Effective Change Control Program Company-Wide
3• Implement Good Validation Practices for Aseptic Processing
I. HandletheChallengeofNewRegulationinSterileFiltration• Risksinfiltrationprocess• TheValidationMasterPlan(VMP)• Methodandconsiderations• Revalidationrequirements
II. AsepticProcessSimulation• Requirementchangesandbackground
ofmediafilling• Environmentalmonitoring
regulatoryrequirements• Interventionandrepresentativeness• Failureinvestigations• Containerintegritytesting
III. InteractiveExercise• Usingareallifeexample,participantsstudyhow
todevelopavalidationmethodforfiltrationprocessvalidation,mediafillandcontainerintegritytesting
Bill Dun, Regulatory and Validation Manager, Merck Millipore, China
1 0 : 3 0 N e t w o r k i n g R e f r e s h m e n t B r e a k
ASEPTIC PROCESSING
QUALITY SYSTEMS — CHANGE CONTROL
VALIDATION — PROCESS VALIDATION
D ay O N E • T u E S D ay , 2 8 F E B R u a R y 2 0 1 2
8:00 Conference Registration and Continental Breakfast
8:30Chairman’s Welcome and Opening Remarks
John Kirchner, Publisher, Journal of Validation Technology and Journal of GXP Compliance, Institute of Validation Technology
Take advantage of the best opportunity to meet potential
clients face-to-face. Build relationships while demonstrating
thought leadership and sharing expertise.
Meet Your MarketIn Recognition of Our Sponsor:
For more information on how to position your company as a sponsor or exhibitor, contact Taylor Biggers at 00+1 339-298-2108 or email [email protected].
1 1 : 0 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 4 - 6 )
4 • Understand, Reduce and Control Variation during Process Validation
5 • Change Control and Configuration Management for Software and Computer Systems
I. UnderstandRegulatoryRequirementsandLearnHowtoDevelopProcedures• Usefulregulatoryrequirements• ExamplesofrecentFDAWarningLetters• Developconfigurationandchangemodels• SOPsandformsforchangesrequests,
releaseandtracking• Howmuchtotestafterchanges
II. LearnHowtoPutCriticalChangesIntoPractice• Usetherisk-basedapproachtodefinethe
criticalityofdifferentchanges
• Thechangecontrolprocessforplannedandunplannedchanges
• Versioningofsoftwareandcomputersystems• Examplesforchanges—Computerhardware,
networks,operatingsystems,securitypatchesandapplicationsoftware
III. InteractiveExercise• Usingsixpreparedcasestudiesfromdifferent
changestocommercialsoftware,computerhardwareandnetworks,smallteamsdeveloplistsonwhattodofordifferentchanges.Theoutcomeisdiscussedwiththeentireteamandresultsarepostedonwww.labcompliance.com/conferences/ivt
IV. BonusMaterial• Foreasyimplementationforchangesof
computerhardwareandsoftwareattendeesreceiveSOPsforplannedandunplannedchangesandasetofcasestudiesofchangeswithrecommendationsonwhattodo.Thematerialcanbedownloadedfromwww.labcompliance.com/conferences/ivt.
Ludwig Huber, Ph.D., Chief Advisor, Labcompliance
I. CriticalStepsforProcessValidationStrategy• Establishvalidationgoals• Planforprocessvalidationattheproduct
developmentphase• Establishrolesandresponsibilities• Documentsandsystemsneeded
II. DevelopaProcessValidationStrategy• Utilisestatisticalmethodsandtools• Developacceptableprocessmapping• Evaluationofprocessesandapplying
riskassessment• Determinewhichcriticalprocessparameters
(CCPs)arecriticalinreducingprocessvariation• Developandvalidatetestmethods• Developcontrolchartsandotherusefultoolsfor
monitoringprocessvariations
III. InteractiveExercise• Participantsreviewanddiscussatypicalprocess
validationstrategyforabiologicalproductandsamplesofprocessmappingandprocesstoolsarediscussed
David W. Vincent, M.Sc., CEO, Validation Technologies, Inc.
6 • Risk Identification and Control in Aseptic Processing
I. AsepticProcessinginaNutshell• Facilities,componentandmaterials,process,
finishedproduct,gowningandcleaningprocedures,EMandtestmethods
• Validation—Mediafill,filtrationefficacy,personneltraining,qualificationandmonitoring,sterilisationofequipment,etc.
II. Risk-basedApproach• Understandregulatoryrequirements• QualitybyDesign(QbD)• Identifypotentialrisks,knowyoursystemsand
knowyourlimits• Buildariskcontrolprogram
III. CaseStudy• Usestatisticalmethodstoperformriskanalysis
andestablishmeaningfulacceptancecriteria
IV. Real-WorldIssueDiscussion• Attendeesparticipateinsharingissuesfromthe
realworldanddiscussingriskassessmentandpotentialresolutions
Weifeng “Frank” Zhang, Master of Engineering, Quality Engineering, Bristol-Myers Squibb Company
ASEPTIC PROCESSING
QUALITY SYSTEMS – CHANGE CONTROL
VALIDATION — PROCESS VALIDATION
1 2 : 3 0 L u n c h e o n
7 • Integrate Risk-based Decision Making into the Computer System Validation Lifecycle
1 3 : 3 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 7 - 9 )
I. EstablishAStandardRisk-basedLifecycleModel• ImpactofGAMPandindustrymaturityon
risk-basedCSVapproaches• Recogniseandintegratetheinherentrisk
differencesofcomputersystemsinfrastructureintolifecycledevelopment
• Assessriskearlytodrivescaledvalidationplanning
• Utilisestandardvendorsandvendorauditmethods
• Documentriskdecisions
II. GatherandAssesstheRiskofRequirements• Understandthebusinessandregulatoryrisk• StakeholderInvolvement• Cascaderiskdecisionsofuserrequirements
intofunctionalrequirements
III. Testing• Documentriskdecisionstoscaletesting• Utilisearisk-basedapproachtodeterminethe
appropriaterigoroftesting
IV. InteractiveExercise• Theindustryisincreasinglyleveraging
contractedresourcestomanageandcontributetoCSVactivities.Thegroupdiscussestheprosandconsofthismodel,anditsimpactonrisk-baseddecisionsduringaCSVeffort
Justin J. Fisher, Senior Manager, Pfizer Inc
VALIDATION — COMPUTER AND SOFTWARE
10• Qualify Virtual Networks and Cloud Computing
I. UnderstandandImplementRegulatoryRequirements• Benefitsandcomplianceissues• Recommendationsfromofficialtaskforces• Infrastructurequalificationversus
systemvalidation• Responsibilities—Theimportanceandexamples
ofqualityagreementswithserviceproviders• Securityanddataleakage
II. PuttheoryintoPractice• Qualificationoftheinfrastructure• Gothroughacompleteprojectforvirtual
networkqualification• Step-by-stepqualificationofcloudcomputing• DocumentationfortheFDAandeveryotheragency
III. InteractiveExercise• Usingpreparedtemplates,attendeesdiscuss
specificexamplesandstepsofvirtualnetworkqualificationandcloudcomputing—
Resultsarepresentedanddiscussedwiththeentireteamandpostedonwww.labcompliance.com/conferences/ivt
IV. BonusMaterial• Foreasyimplementationvirtualnetworksand
cloudcomputingprojectsattendeesreceiveSOPsforplannedandunplannedchangesandasetofcasestudiesofchangeswithrecommendationsonwhattodo.Thematerialcanbedownloadedfromwww.labcompliance.com/conferences/ivt.
Ludwig Huber, Ph.D., Chief Advisor, Labcompliance
1 5 : 3 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 1 0 - 1 2 )
9• Develop Effective Strategies to Control Microbiological Contamination
I. EnvironmentMonitoringFundamentals• Howtotrendenvironmentaldata• Aretraditionalgraphicmethodsadequate?• Determinealertandactionlimits
II. AComprehensiveApproachtoEstablishmentofAlertandActionLimits• Howtodealwithtoomanyzeroobservations• Resolveheterogeneityincontaminationrate
frommultiplesites• Acomprehensivestrategybasedon
statisticalmodeling
III. InteractiveExercise• Participantsreviewademonstrationofan
exceltoolusedtosetalert/actionlimits
Harry Yang, Ph.D., Senior Director, MedImmune, LLC
1 5 : 0 0 N e t w o r k i n g R e f r e s h m e n t B r e a k
ASEPTIC PROCESSING —MICROBIAL CONTAMINATION CONTROL
8 • Quality Risk Management System — Utilise Quality Risk Management Methodology and Tools throughout the GMP Environment
QUALITY SYSTEMS — CHANGE CONTROL
VALIDATION — COMPUTER AND SOFTWARE
11• Audit and Conduct a Gap Analysis of Your Risk Management System
I. DeterminetheStatusofYourQualitySystems—WhatIsGoodSupposedtoLookLike• AttributestohaveinaQualitySystemdesign• Goodtraininganddocumentation• ValidationMasterPlanandSOPs
II. PlanningInternalAudits—HighestRiskstoProduct,PersonnelandtheBusiness• Benchmarkagainstindustry• Reviewpreviousauditobservations• Limiteachaudittooneortwosystems
III. IdentifytheGapsandAssignRisk• Howtoselectwhattoworkonfirst• Riskmapping• Setrealistictimelines
IV. ClosetheGapAndMitigateRisk—TrackAndReport• Bestrategicbydesigningsystematicsolutions• Trackagainstestablishedtimelines
Jeffrey R. Felker, Manager, Pharmaceutical Technology, sanofi pasteur, Inc.
12• Microbiological Contamination Control Practices — Control Non and Spore Forming Microorganisms
I. MajorSourcesofMicrobiologicalContaminationwithintheCleanroom• Identifydifferenttypes,sources
androutesofcontamination• Recognisetheimpactandeffects
ofcontamination• Understandhowpersonnelcontribute
tocontamination• Seasonalvariationanditsimpacton
microbialproliferationandfloratype
II. MethodforControllingNonandSporeFormingMicroorganisms• Implementcontrolsputtominimise
contaminationfrompersonnel• Majorsourcesofcontamination• Fowningandde-gowning• Assesshowacleanroomistested
andmonitored• Developacontaminationcontrolprogram
forcleanroomenvironments
• Measuretheperformanceofacleanroom• Theimpactof‘microbialcontamination
ofthecleanroom
III. InteractiveExercise• Participantsdiscusscurrentregulatory
observationandfindingsassociatedwithasepticprocessesandcleanroomenvironments
David W. Vincent, CEO, M.Sc., CEO, Validation Technology, Inc.
ASEPTIC PROCESSING — CONTAMINATION CONTROL
QUALITY SYSTEMS — RISK MANAGEMENT
I. QualityRiskManagementConcepts• Keyriskmethodandtools• Industrytrendsandregulatoryreview• GMPsandapplicableguidance• Facilityissuesanddesignconsiderations• GMPutilitysystemsdesign• Mechanical/HVACdesign• Qualificationandcommissioning• Changecontrol
II. ImplementRiskManagementinFacilityDesign• Discussfacilitydesignconceptsrelatedto
currentGoodManufacturingPractices(cGMPs)• Explaintherolesandresponsibilitiesof
projectteammembersindefiningfacilityneedsandscope
• Citeengineeringdesignprinciplesrelatedtodrugproductmanufacturing
• Identifypharmaceuticalandbiotechnologyprocessattributesthatimpactfacilitydesign
• Locatecurrentindustryguidancedocumentsthatimpactfacilitydesign
• Definethefacilityandequipmentlifecycledefinitions
• Discussprojecteconomicsanditsimpactonfacilitydesign
• Describecurrentindustrytrendsimpactingfacilitydesignandconstruction
Jack Chu, PE, Manager, Technical Support, Merck & Co., Inc.
17:00 CLOSE OF DAY ONE • 17:00-18:00 NETWORKING, WINE AND CHEESE RECEPTION
D A y t w O • w E D n E s D A y , 2 9 F E b r u A r y 2 0 1 2
8 : 0 0 C o n t i n e n t a l B r e a k f a s t
8 : 3 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 1 3 - 1 5 )
13• Streamline the Validation Process
I. WheretoBegin?• Guidelinesandinformationtoaidin
streamliningvalidation• Planningandimplementation
II. RolesandResponsibilities• Riskmanagement• Integratedcommissioningandqualificationand
leveragingoftesting• Documentationsystemandrequirements
• Approachtoqualificationtesting• Deviationsandchangemanagementsystems
III. ImplementaSuccessful,StreamlinedValidationProcess• Changeincultureandmindsetwhileensuring
adherencetoqualitycompliance• Cost,timeandresources• Challengestofaceandlessonstolearn• Translationintosustainingoperations
IV. InteractiveExercise• Participantsreviewanddiscussacasestudyon
wherethevalidationprocesswasstreamlined
Elaine Kelleher, Validation Lead, Merck, Sharp and Dohme
14 •Corrective and Preventive Action – Implement a Program that Impresses a Regulatory Investigator
I. ProcessFrameworkandUtilisation• Strongprocessframeworksandrelationships• TargeteduseofCAPAprocesses• OverusingCAPA
II. EnsuringaThoroughCAPAProcessfromStarttoFinish• Investigations,trendanalysisandother
CAPAtriggers• BuildingqualityintotheCAPAprocess• Stakeholderinvolvement• Usingmanualandautomatedimpact
analysestoguide• CAPAprocessoutputs• Documentationthattellsastory
• Measuringsuccess• Outputstoothercontinuous
improvementprocesses
III. InteractiveExercise• Participantsdiscuss“reallife”experiences
ofwhyCAPAshavefailedtomeettheirintendedpurpose
IV. BonusMaterial• Impactanalysistools
Justin J. Fisher, Senior Manager, Pfizer Inc
QUALITY SYSTEMS — CORRECTIVE AND PREVENTIVE ACTION (CAPA)
VALIDATION — MASTER PLANNING
15•Develop a Lean Cleaning Validation Program
I. DefineCleaningValidationRequirements• Ensurecorporateandregulatory
requirementsaremet• Definethecleaningvalidationlifecycle• Defineyourequipmentandsoils—
Afamily/grouping/matrixapproachtotesting• Definetherequiredtestingforyoursoils• Whatpre-introductioncleaningstudiesare
requiredbeforetesting?
II. ExecuteCleaningValidationStudies• Developthetestprotocols• Visualinspectionandswabtraining• Isyourcleaningcycleoptimisedforsuccess?• Definethecleaningvalidationcontrols• Summariseyourresults
III. Leanouttheprocess• Monitortheprocessovertime• ImplementaCOPwashervalidation• Incorporateriskassessment• Theconceptof“supersoils”andtheirbenefits
IV. InteractiveExercise• ParticipantswalkthroughRocheSingapore
TechnicalOperationsCleanHoldStudyforourEcolifacilitywherethegroupexecutedasifmakingproduct;transferringthebiolodetothenextunitoperations.Thisprovidesthecandidateanunderstandingofwhatlevelofbioburdenisobservedateveryunitoperationsoftheentireprocess
Todd Mabe, Principal Technical Manager — Validations, Roche Singapore Technical Operations Pte Ltd
1 0 : 0 0 N e t w o r k i n g R e f r e s h m e n t B r e a k
16•Documentation Requirements for Validation
1 0 : 3 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 1 6 - 1 8 )
VALIDATION — MASTER PLANNING
ASEPTIC PROCESSING — CLEANING VALIDATION
I. ProvideanOverviewoftheValidationLifecycleapproach• DeveloparobustValidationMasterPlan• Designdocumentationandtheirdevelopment• Performriskassessmentandusetheirresultsto
definetestingrequirements• Leveragecommissioningdocumentation
II. ExpectationsinQualificationProtocols• Howmanypeopleneedtosignthedocument?• Definethecontent/strategy• Definetestingcontrols,pre-requisitesand
acceptancecriteria• Recordingtheresults/observations
III. ExpectationsinSummaryReports• Howmanypeopleneedtosignthedocument?• Definethecontentsthatmustbediscussedin
summaryreports• Concludethevalidationbydiscussingdeviations
andresults
IV. InteractiveExercise• Participantsanalyzethevalidationlifecycleof
PUREPharma(anonexistingIVTSingaporeconferencecompany)anddeterminetheareaswecansavemoneyandtimeondocumentationbeforeevenexecutingthequalificationwork
Todd Mabe, Principal Technical Manager – Validations, Roche Singapore Technical Operations Pte Ltd
1 3 : 0 0 C h o o s e B e t w e e n T h r e e 9 0 - m i n u t e S e s s i o n s ( 1 9 - 2 1 )
I. QualificationofFacility,ClassifiedAreaandGMPUtilities• Formtheprojectteamandidentifydeliverables• Developmentofuserrequirements• Performsystemimpactassessment• Developthevalidationmasterplan• Developthecommissioningplanandproject
testplan• Performcomponentcriticalityassessments• Developthecommissioning,IQ,OQand
PQprotocols
II. ExaminetheCriticalRequirementsfortheProject• Assembleaneffectiveprojectteamandassign
roles,responsibilitiesandauthority• GMPs,GEP,CQAanddesigndocuments• Performscienceandtechnologybased
impactassessments• Formulateanintegratedcommissioningand
qualificationstrategyusingtestplans• Developacontentoutlineofthecommissioning
andvalidationmasterplans
• ConstructtestplansforGMPutilitysystem• Prepareanoutlineofthequalification
protocolcontents
III. InteractiveExercise• Participantsdevelopanoutlineforthecontents
ofacommissioningplanandvalidationmasterplananddevelopatestplantoimplementtheintegrationofcommissioningandqualification
Jack Chu, PE, Manager, Technical Support, Merck & Co., Inc.
17•Ensure Product Quality through Stability Design and Analysis — A QbD Approach
18•Establish Risk-based Cleaning Validation Acceptance Criteria
I. SettheStage• Typesofprocessesand
residuesunderconsideration• Typesofsamplingmethods• CriticalProcessParameters(CPPs)• CriticalQualityAttributes(CQAs)
II. EstablishRiskBasedLimits• SetacceptancecriteriafortheCPPs• Whattodowhenyoudon’thaveadose• Theconundrumofsurfacearea• Whataboutbiologicalacceptancecriteria?• TheuseofUSPwaterspecifications• Trendsintheindustry
III. InteractiveExercise• Usingareallifeexample,participantsperform
aMACcalculationforadetergentusedinthecleaningprocess
IV. BonusMaterial• Referencematerialforcalculations• Relevantarticles
Dawn Tavalsky, Deputy Director Cleaning Validation, sanofi pasteur, Inc.
19•Commissioning and Qualification for Facility, Equipment and GMP Utility Systems — A Quality Risk Management Approach
VALIDATION — EQUIPMENT QUALIFICATION
ASEPTIC PROCESSING — CLEANING VALIDATION
QUALITY SYSTEMS — QUALITY BY DESIGN (QbD)
1 2 : 0 0 L u n c h e o n
20•The ICH Q10 Journey — Understand the Principles and How to Implement QbD
I. ICHProcessandComplimentaryDocumentationtoICHQ10• ICHQ10—“Cliffnotes”toICHGuidances• Otherimportantguidancedocuments
II. LifecycleApproachtoManagingQualityProducts• Challengeprocessesandsystemsindevelopment• ConfirmthattheCPPidentifiedare
reproducibleinvalidation• TrackCPPsandCQAsduringroutinemonitoring
III. Cost,Risk,BenefitofQbDandtheQualitySystem• BenefitofQbD• Standardisationandsystematicapproach
toproduction• Costofdevelopmentversusdeviations• Understandtheinteractionsbetween
CPPandCQA• Matrixing—Leverageknowledge
IV. MaintenanceandContinuedImprovement• Conductagapanalysis• Internalauditsandroutinemaintenance• Replace“activity”withdiscipline• Identifyopportunitiesforoptimisation
Jeffrey R. Felker, Manager, Pharmaceutical Technology, sanofi pasteur, Inc.
QUALITY SYSTEMS — QUALITY BY DESIGN (QbD)
I. ChooseStabilityDesigns• Designshouldsatisfythegoalofthe
stabilitystudy• Developstabilitydesignbasedon
riskmanagement• Increasestudyefficiencythrough
matrix/factorialdesigns• Preemptregulatoryissuesusingaccelerated
stabilitydesign
II. StabilityDataAnalysisandMonitoring• Measurestabilityattributeswithuncertainty• Determineshelflifetoprovideproduct
qualityassurance—Aunifiedapproach• Usedevelopmentdatatopredictcommercial
productstability
III. Real-LifeApplicationsofStabilityStudies• Formulationdevelopment• Comparabilitystudy
Harry Yang, Ph.D., Senior Director, MedImmune, LLC
21•Organisation, Training and Process Flow for Sanitisation of an Aseptic Facility
23•Common Pitfalls in Aseptic Processing and Cleaning Validation
I. IntroductiontoRootCauseAnalysis• Methodsusedduringdeviationinvestigations• Structuredthoughtprocesstools• Reallifeexamplesofthe“toolsinaction”• Tyingitalltogethertogetattherootcause
II. LearningfromourMistakes• Commonerrorsanddeviations• Correctiveactionanalysis—
Whatcanbedonetopreventrepeats• Controlmonitoring—
Howtoensureyour“fixesstick”
III. InteractiveExercise• Usingareallifeexample,participantsperform
aninvestigationintoacleaningvalidationfailureutilizingstructuredthoughtprocesstoolsanddeveloprecommendationsforcorrectiveactions
IV. BonusMaterial• Sixsigmatooltemplates• Relevantarticles
Dawn Tavalsky, Deputy Director Cleaning Validation, sanofi pasteur, Inc.
1 6 : 1 5 C L O S E O F C O N F E R E N C E
I. OverviewofanAsepticFacility• ISOandEUstandards• ReviewofFDAwarningletters• HVACdesign,typeofprocess,sanitisation,
EM,personnel
II. EstablishanEffectiveSanitisationProgram• Scopeofworkinthefacility• Choosesanitisers,disinfectantsandsporicides
• Cleaning/sanitisationprocedures• Sanitisationprocessflow• Validation
III. EssentialElementstoMaintainSuccessful• Teamresponsibilities• EMandtrainingprogram• Qualityreviewandinvestigationprocedure
IV. InteractiveExercise• Usingatemplate,participatestosimulatethe
validationapproachforthesanitisationofanasepticfacility
Weifeng “Frank” Zhang, Master of Engineering, Quality Engineering, Bristol-Myers Squibb Company
1 4 : 3 0 N e t w o r k i n g R e f r e s h m e n t B r e a k
1 4 : 4 5 C h o o s e B e t w e e n T w o 9 0 - m i n u t e S e s s i o n s ( 2 2 - 2 3 )
22•Identify and Qualify Critical Utilities
I. IdentifytheCriticalUtilities• Regulatoryrequirementreview• Howthesystemscouldaffecttheproduct
andprocessquality
II. TheTypicalConstructionTypeforEachSystem• Purifiedwatersystem• Cleansteamsystem• Processair• HVAC
III. HowtoQualifytheDifferentSystems• Usethereallifeexamplestodemonstratethe
duequalifiedcontentsforeachsystem
IV. InteractiveExercise• Participantsdiscussdesignand
operationissues—PW,cleansteamgenerator,processairandHVAC
Zhang Xuexin, Bachelor (Master in study), Engineering Manager, Novozymes (China) Biopharma Co. Ltd.
ASEPTIC PROCESSING —CLEANING VALIDATION
VALIDATION — CRITICAL UTILITIES
ASEPTIC PROCESSING — PROCESS FLOW
YouwillbenefitfromattendingthiseventifyouareaVicePresident,Director,ManagerorSupervisorfromapharmaceutical,biotechoramedicaldevicecompanywithresponsibilitiesinthefollowingareas:
QA/QC • Validation • Engineering • IT • Laboratory • Regulatory Affairs • Science • Microbiology
Thisconferencewillalsobenefitsuppliersandconsultantsinthefollowingareas:
Validation/GMP Compliance • Contamination Control • Software for Quality Improvement
Who Should Attend
IVT/CBI 600 Unicorn Park Drive • Woburn, MA 01801 • USA
• Registration Fee: Standard Advantage Pricing (register by 12/23/11)
2-Day Conference $2095 USD $1795 USD
Advantage Pricing — Register by 22 December 2011 and SAVE $300. Fee includes continental breakfast, lunch, wine and cheese reception, refreshments and Online Compendium. Please make checks (in U.S. funds drawn on a U.S. bank) payable to CBI Research, Inc. (No personal checks accepted) Advantage Pricing may not be combined with other discount offers, special category rates or promotions. Discounts only apply to standard rates.
• Team Discount: Your organisation may send 1 executive free for every 3 delegates registered.
All registrations must be made at the same time to qualify.
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Cut-off date is 13 February 2012. Reservations made after the cut-off date or after group room block has been filled (whichever comes first) will be accepted on a space and rate availability basis. Rooms are limited so please book early.
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• Venue: The Pan Pacific Hotel 7 Raffles Boulevard • Marina Square, Singapore 039595 Phone: Singapore 00+1-800-7722-4342 • Inside the U.S. 800-324-4856
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FULL CONFERENCE (before 12/23/11) ................................................... $1795
FULL CONFERENCE (after 12/23/11) ........................ $2095
We would like to take advantage of the TEAM DISCOUNT (see left for details).
I cannot attend. Please send me the link to the Online Compendium.
Do you have any special needs? _________________________
KEY CODE (appears above mailing address): _________________________
MailIVT/CBI Registration Dept.600 Unicorn Park Drive Woburn, MA 01801 • USA
The Next Best Thing to Being There…Order the Online Compendium if you would like to capture what you’ve missed at the conference. It couldn’t be easier. The link to the online compendium is available for only $298 and includes the conference agenda, presentations and speakers’ biographies. Don’t miss out on this valuable information presented
by industry leaders exclusively at this event. Simply fill out the order form and submit via phone, fax or website and you’ll receive the link to the
Online Compendium within 2 weeks after the conference.
28-29 Fe b r u a r y 2012 T h e Pa n Pa c i f i c H o te l • S i ng a p o r e
R e g i s t e r b y 2 2 D e c e m b e r 2 0 1 1 a n d R e c e i v e $ 3 0 0 O f f o f Y o u r R e g i s t r a t i o n F e e !
Implement Cutting-Edge Programs for your Organisation:
• Validation—Process,Computer/Software,Facilities,UtilitiesandEquipment
• Quality Systems—ChangeControl,CAPA,Risk,InvestigationsandQbD
• Aseptic Processing—ProcessFlow,ContaminationControl,CleaningValidation,OrganisationandTraining
aND MuCH MORE! SEE INSIDE FOR DETaILS!
Achieve Manufacturing Excellence through Optimal Quality Practice
4 Easy Ways to REgistER
MailCBI Registration Dept. 600 Unicorn Park Drive Woburn, MA 01801 • USA
[email protected] include all information requested on registration card.
WeBSiTewww.cbinet.com/valweeksingapore
Phone00+1-339-298-2100(800-817-8601 inside the U.S.)
Compliance Week IVT’s2nd Annual Validation and cGMP
PRSRT STD U.S. Postage
PAID Gallery
ANY QUESTIONS OR TO REGISTER PLEASE cONTAcT RobeRt bouciniPhone: 339-298-2150 • Fax: 781-939-2459 • [email protected]
ANY QUESTIONS OR TO REGISTER PLEASE cONTAcT RobeRt bouciniPhone: 339-298-2150 • Fax: 781-939-2459