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Pharma Packaging andTechnical Operations
MasterClass
Online MasterClass 13-14 August 2020
Dieter Mößner
An extra Session on Artwork Management Best Practices and Deepdive into Esko Digital collaborative platform by
Jackie Leslie
Account Executive /
Business Development
Esko I Brand Solutions
Steven Brookes
Solution Architect
Esko I Brand Solutions
• Thetechnicalandorganisationalrequirementsandproceduresofpharmaandhealthcarepackagingandtechnicaloperations
• Anti-counterfeiting,serialisationandtamperevidenceonthepackagingofmedicinalproducts• Packagingset-upandchallenges-Secondarypackaging• Thestepsoflabellingandpackagingprocess• Inprocesscontrols-Measurestoavoidmix-ups-Lineandlogisticconcepts• Qualificationofpackaginglines• Conceptsforlineclearance,commonrisksandtypicalfailures,rolesandresponsibilities• Practicalsolutions
KEY TAKEAWAYS
Pharma Packaging and Technical Operations
MasterClass
[email protected] +36 1 848 0515www.glceurope.com
13-14 August 2020 Online MasterClass
IntroductIon
WhoShouLdATTend?
LeArnIngouTCoMeS
The online training course will support you in collecting, sorting and proper understanding
of the requirements of the procedures of pharma and healthcare packaging and technical
operations. The trainings curse will also focus on anti-counterfeiting, serialisation and tamper
evidence on the packaging of medicinal products. Generally the course will cover a 360 degree
view on healthcare and pharma packaging and packaging operations.
This course is designed for executive and operational managers of pharmaceutical
companies, especially from packaging operations, as well as IT, artwork operators and
engineering staff, responsible for the implementstion or operation of packaging and technical
operations. Suppliers of packaging and authentication technology and pharmaceutical
packaging companies are also welcome.
It is the course’s goal to inform about the technical and organisational requirements and
procedures of pharma and healthcare packaging and technical operations. Also its
technical, legal and procedural requirements and best practices will be dealt with. Generally, the
challenges and solutions how to comply with the technical and organisational requirements
and procedures of pharma and healthcare packaging and technical operations including
special topics such as anti-counterfeiting, serialisation and tamper evidence on the packaging
of medicinal products are the core content of this training course. Best practice examples will
demonstrate how the pharma packaging operations and requirements can be managed in the
best possible way.
The online training course is also organized to foster internal discussion, sharing ideas and
exchange of internal knowledge amongst participants and the trainer in order balance
different levels of knowledge and experience in the training subjects. The online training
course will also help to change the perspective of thinking of the participants to consider their
own expertise and behavior.
Pharma Packaging and Technical Operations
MasterClass
[email protected] +36 1 848 0515www.glceurope.com
13-14 August 2020 Online MasterClass
Trainer:
Dieter MößnerProject Engineer PharmaEdelmann GmbH
For23years,Dieter Mößner hasbeenworkingatedelmannasatechnical
project manager. he leads projects in Braille application, serialisation,
tamper evidence and anti-counterfeiting of pharma and consumer good
packagingandconsultscustomersandartworkagenciesinartworkcreation,
print data communication and typesetting workflows. dieter composed
parts of the guidelines “Braille on Folding Cartons”, published by the
europeanCartonMakersAssociationeCMA.heisConvenorofCen/TC261/
SC5/Wg12“Marking”.ThisworkinggroupattheeuropeanCommitteefor
Standardisation Cen has created the european standards en 15823:2010
“BrailleonPackagingforMedicinalProducts”anden16679:2014“Tamper
VerificationFeatures forMedicinalProductPackaging”.SinceMarch2013,
hehasbeenchairmanofthepackagingstandardscommitteenAVpatthe
germanStandardsInstitutedIn.
Jackie Leslie:Account Executive / Business Development, Esko I Brand Solutions
Jackie has 18 years of experience in labeling and artwork management
andfocusesspecificallyonthemedicaldeviceandpharmaceuticalsectors.
Workingwith companies to understand business challenges and industry
bestpractices,Jackie’sgoal is tohelpcompanies identifyopportunities to
increasespeedtomarket,improvequality,andreducerisk.
Steven Brookes: Solution Architect, Esko I Brand Solutions
Apackagingprofessionalof25years,witharichanddiversecareeracross
the graphics supply chain, from pre-media production to the delivery of
enterprisesoftwaresolutionsandservices.
Steven has a successful background in the implementation of software
solutions across the Consumer Packaged goods, Life Science and retail
sectors. Additionally, having held senior operations and technical
management roles within internationally based pre-media organizations,
hehasacompleteunderstandingofgraphicproductionandtheunderlying
technologiesrequiredtodeliverit.
Pharma Packaging and Technical Operations
MasterClass
[email protected] +36 1 848 0515www.glceurope.com
13-14 August 2020 Online MasterClass
DAY1
Break10:00
Lunch Break12:40
END End of day 116:00
08:30
11:10
11:50
12:30
14:00
08:40
09:20
10:30
Lecture 0: Scope/Introduction
Lecture 4: Packaging components (product, leaflet, box) Critical stepsInprocesscontrols-Measurestoavoidmix-ups-Lineandlogisticconcepts• IsthereanyrequirementforthequalificationofthepeoplethatperformtheInProcessControlvsthequalification
ofthepeopletrainedforVisualInspection?• What’sthecommonstandardapproach?
Lecture 5: Anti-Counterfeiting and Patient ComplianceAnti-counterfeitingofmedicinesandofpackagingPatientcomplianceandpatientadherence
Wrap-Up and Q & A
Artwork Management Best Practices and Deepdive into Esko Digital collaborative platform.Asregulatoryscrutinycontinuestopropagatelifesciences,itisvitalforpharmacompaniestoimplementgoodpracticeguidelinesandtechnologyintotheirlabelingandartworkoperationstopreventerrordeviationsanddecreaseproductrecalls.Implementingdigitalandautomatedprocesseshelpaddressregulatoryrequirements,reducecosts,andimprovequalityandvisibilityacrossthelabelingandartworklifecycle.duringeskosessionyou’llget:-AnoverviewoftheBestPracticescoveringthe3componentsofabestinclassArtworkandLabellingManagementequation:People + Process + Technology -ApresentationofeskoWebCenterdigitalcollaborativeplatformbenefitsfollowedbyareallifedemonstrationofitsmainfeatures,covering:- PackagingSpecificationmanagement- ProcessManagement- reviewandapprovalManagement- dashboardsandSearching- ContentManagement
Lecture 1: Introduction into packaging - Overview steps of labelling and packaging processregulatoryrequirements-requirementsforreconciliationstepsduring/afterpackaging(plungerrod,label,leaflet,box)reintroductionoftheejects(vialandsyringe):• howtoinspect?• howtoreintroduce?• howtodocument?howoften?• Isavalidationrequired?• howtomanagetheejectreintroducedafterthesealingoftheplasticblistertothelid?
Lecture 2: Labelling and challenges - Technical aspects of labelsVariabledata-Labelreconciliation• Isarequirement?• howmuchshouldbeaccurate?• Accuratereconciliationvs(checkofthepresenceofthelabeloneachsyringe+appropriatelineclearance).• Isitoknottohaveacontinuousmonitoringofthecorrectnessofthevariabledata?• Whatshouldbetherightbehaviourafterastandstillorafteralongstopofthemachine?
Lecture 3: Packaging set-up and challenges - Secondary packagingTertiary packaging - Outer coverage• Whichkindofmachinecontrolisrequired?howoften?• howtosimulateandexecuteallthemachinecontrol(forexamplewrongvariabledata,nolabeletc).• howtochallengethemachineandwhichinstrumentsbeforetostartabatch?• Arethemachinecontrolsrequiredafteraformatchange?• howdoyoudeterminewhichchallengesandhowoften?
All dates and times are expressed in UTC/GMT+2 on the Agenda.
Pharma Packaging and Technical Operations
MasterClass
[email protected] +36 1 848 0515www.glceurope.com
13-14 August 2020 Online MasterClass
DAY2
Break09:50
END End of day 212:35
08:30
11:30
12:30
09:10
10:30
Lecture 6: Concepts for line clearance, Common risks and typical failuresrolesandresponsibilitiesPracticalsolutions• IsitrequiredtoperformariskassessmentorusingFMeAorhCCPtoidentifythebestlineclearanceapproach?• Whichkindofmaterialcanyouleaveandwhichnotinthelineattheendofabatch,waiting
forthefollowing(ex.Plunger-rod)?• howisitcriticalthetraining(isanonTheJobtrainingrequired?)?• howmanypeoplehavetocheckthelineclearance?Alwaystwo?• Whichdepartmenthastotrainthenewpeople(Manufacturing?Quality?etc).• Isitnecessarytohaveariskassessmenttoidentifyandmanageallthecriticalpositions?
Lecture 9: Tamper Evidence and tamper Verification features on the packaging of medicinal products
Wrap-Up and Q & A
Lecture 7: Qualification of packaging linesoverviewparameterstobecalibratedoverviewequipmenttobequalified• howtoapproach?• Whataboutthefrequencyoftherequalification?• QualificationvsValidation(inparticularforVisualInspection)?• howtochoosethecriticalparameters/equipment?• Isthere-validationrequired?• howoften?
Lecture 8: Serialization, Track and traceoverviewtechnicalsolutions• Incaseofare-processofanentirebatch,howtomanagethebatchalreadyserialized?
Andincaseofare-processofhalfabatch?
All dates and times are expressed in UTC/GMT+2 on the Agenda.
Media Partners
Pharma Packaging and Technical Operations
MasterClass
[email protected] +36 1 848 0515www.glceurope.com
13-14 August 2020 Online MasterClass
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Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business.Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources.Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest know-how’s and benchmark yourself higher against the competition while enjoying a 5 star environment.
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