www.glceurope.com Pharma Packaging and Technical 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 • The technical and organisational requirements and procedures of pharma and healthcare packaging and technical operations • Anti-counterfeiting, serialisation and tamper evidence on the packaging of medicinal products • Packaging set-up and challenges - Secondary packaging • The steps of labelling and packaging process • In process controls - Measures to avoid mix-ups - Line and logistic concepts • Qualification of packaging lines • Concepts for line clearance, common risks and typical failures, roles and responsibilities • Practical solutions KEY TAKEAWAYS
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www.glceurope.com
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
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 6: Concepts for line clearance, Common risks and typical failuresrolesandresponsibilitiesPracticalsolutions• IsitrequiredtoperformariskassessmentorusingFMeAorhCCPtoidentifythebestlineclearanceapproach?• Whichkindofmaterialcanyouleaveandwhichnotinthelineattheendofabatch,waiting
• Development of generics: From R&D to GMP MasterClass
• Risk and Pharmacovigilance MasterClass
• LifeScience Micro MBA MasterClass
• Signal and Risk Management in Pharmacovigilance MasterClass
• Digitaliza� on in Pharma 2021
HEALTH AND SAFETY EVENTS
• Advanced Human Error MasterClass
• European HSE Management Forum 5.0
• MBA for HSE Prac� oners MasterClass
• HSE360 Summit 2021
• European HSE Management Forum 6.0
HUMAN RESOURCES EVENTS • Sales Incen� ve Plans MasterClass
• Advanced Compensa� on and Benefi t MasterClass
• Personal Eff ec� veness Tools MasterClass
• Agility in HR
• 15th HR Minds TalentON Forum
• Advanced Organisa� on Design MasterClass
• HR Minds Forum
CROSS INDUSTRY EVENTS • Women in Leadership Summit
• Machine Learning MasterClass
• Climate Risk Financing MasterClass
• Coaching MasterClass
• Situa� onal Leadership MasterClass
• Audit Summit 2020
• Agile Workplace Design Forum
• Supply Chain Management Forum
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