BestPracticesinEnvironmentalMonitoring:CoveringSteriles&NonSteriles

Wednesday2 March2016TheOxfordshireHotel,Oxford
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Attend&receiveafreecopyofPharmigsEnvironmentalMonitoringReviewPublication

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Registrationwithtea/coffee
Chairsintroduction
DavidKeenMicrobiologyManager,GlaxoSmithKlineandPharmigChair
OverviewofrelevantregulatoryguidelinesandUSPchangesUSP<1116>
and<1115>
Regulationsrelatingtoenvironmentalmonitoring;
KeyGMPpoints;
MainaspectsofUSP<1116>;
HowdoesUSP<1116>differfromEUGMPandwhatshouldyoudoaboutis?
TimSandleHeadofMicrobiology,BPL
AnOverviewoftheEnvironmentalMonitoring(EM)Strategy
Usingariskbasedapproachtogetthe bestoutofyourEMprogram
EMlocations,sortingthepointless fromthevalueadding
WhichEMlocationsandwhat techniquetouseforthem
DavidKeenMicrobiologyManager,GlaxoSmithKlineandPharmigChair
Morningbreakwithtea/coffee
EnvironmentalMonitoring:IncubationStrategies
Whatisenvironmentalmonitoringtryingtodo?
Whichagarshouldyouselect?
Shouldoneortwoagarsbeused?
Whichistheoptimaltemperature?
Forhowlongshouldyouincubatefor?
Whattypesofmicroorganismscanyouexpecttodetect?
TimSandleHeadofMicrobiology,BPL

BuffetLunch
EnvironmentalMonitoringIdentification(ID)Strategy
InterpretationofFDAAsepticGuidanceandEUAnnex1
HowtomanageIDfornonsterileEM
Howmanycoloniestoidentify?
Howfartogo:morphologically,photographiclibrary,biochemicalanalysis?
JulieRobertsIndependentConsultant,JRobertsAssociates
InvestigationsandCAPAforEnvironmentalOutofSpecs(OOS)
Tellingthewholestory
ErikaNotmanPrincipal,NotmanConsulting

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Afternoonbreakwithtea/coffee
DataIntegrity(DI)withinnonsterileenvironmentalmonitoringoperations
MythbustingDataintegrityisnotonlytodowithHPLC
Whatisdataintegrity?
ALCOAprinciples
HowtoaudityourfacilityforDIissues
JulieRobertsIndependentConsultant,JRobertsAssociates
Q&ADiscussionSessionwithPresenters
Howshouldwegoaboutsettingalertandactionlimitsforenvironmental
monitoring?
ClosingRemarks

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