BBB enchmnahrkBfoI - ACISSB Training 28_29Feb 2012.pdf · Cleaning Validation, sanofi pasteur, Inc. Zhang Xuexin, Bachelor (Master in Study), Engineering Manager, ... Novartis Singapore

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


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


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


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



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


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


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


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


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


16•Documentation Requirements for Validation


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


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


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


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


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


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


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



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)

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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

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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

[email protected]