MES & Process Minds 2012

http://pharma-mes.we-conect.com

ImprovIng QualIty & ComplIanCe andInCreasIng operatIonal exCellenCe wIthmanufaCturIng exeCutIon systems Inpharma & lIfe sCIenCes IndustrIes

24th – 25th september 2012 | novotel BerlIn am tIergarten

more than 15 Case studIes | ICeBreaker sessIon | world CafÉ sessIon | Challenge your peers

researChed & developed By

mes & process minds 201224th – 25th septemBer 2012 | novotel BerlIn am tIergarten



oVerViewmes & process minds 2012

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dr. peter Iles-smithmes technical dIrector - global manufacturing & supplyGlaxoSmithKline plc / UK

Carson sublettvice president operations & site directorDSM Pharmaceuticals / The Netherlands

Christoph leblassociate director automationGenentech Inc., Hillsboro, OR / USA

paul kellymes director Corporate operationsGenzyme Industrial Affairs IS / Ireland

dr. Bernd lehledirector Biopharma electronic management systemsBoehringer Ingelheim Pharma GmbH & Co. KG / Germany

mark mckechnie lead mmdIt / global servicesMSD Carlow Site / Ireland

michele vecchihead of manufacturing Information systemChiesi Group / Italy

laura leidirector, global technology group Baxter BioScience / USA

stefan tautscherglobal head ItIntercell AG / Austria

Jens seesthead of department for Quality assurance It ComplianceLEO Pharma A/S / Denmark

dr. anke meyerBusiness unit director pharma and md&dJanssen-Cilag AG / Switzerland

mehron mirianCsv leadB.Braun Medical Inc. / USA

marcel de grutterhead of It portfolio management epoAbbott Healthcare Products B.V. / The Netherlands

marian phelansap / mes / material management leadMerck Sharp & Dohme / Ireland

John dzelmesenior systems analystRoche Diagnostics / Switzerland

nirav patelmanufacturing systems engineerBristol-Myers Squibb / USA

Johann wieserhead automation & mesF. Hoffmann-La Roche AG / Switzerland

Brian duranIs project leaderSanofi Pasteur / France

> strategies and criteria for the selection of mes, technical and organisational requirements for mes and selection of appropriate systems

> distributed systems from the perspective of global harmonisation

> Compliant documentation, regulatory guidance and Quality assurance for manufacturing

excellence / mes as the bridge to achieve pat and Qbd

> automation infrastructure for operational excellence: remote operations management,

automation services strategy & in-plant mobility solutions

> mes Infrastructure for Cloud Computing within a regulated Industry / gmp environment

> systemised control of production & manufacturing intelligence: Integrated It systems and mes

management in process industries operations> next generation It and process control solutions:

Closing the gap between r&d and manufacturing through intelligent mes

> review the value of early employee engagement and training for mes

> Cost management and effectiveness analysis for mes projects

> serialisation requirements for mes> Integration of mes & mobile devices and the use

of cloud services> gradual reduction of It isolated applications on a

production level by use of platform solutions> Integration of sap business systems with applications in production control> Integration of sap mII & sCm> mes as a comprehensive integration platform:

with descriptive real-time and detailed information from production, making business processes faster and more flexible

> Batch record standardisation: how batch records were first standardised on paper before going electronic

> mes in emerging Countries / BrIC – gmp requirements for application

SPEAKERS MAIN TOPICS

BUSINESS PARTNERS

we.CONECT business peerstake advantage of solution-oriented individual meetings that we can arrange withthese partners before andduring the conference.




aGendaicebreaKer session | sunday, 23rd septemBer 2012

20.00 | round tablesPre-conference drinks and Icebreaker Round Tables with speakers, business partners & participants

ICeBreaker round taBle 1Quality by Design „QbD“ in MES-Concept – How companies deal with QbD, what are their challenges and new proposed approaches from ISPEMehron Mirian, Csv lead, B.Braun Medical Inc. / USA

ICeBreaker round taBle 2Manufacturing Intelligence through coupling BI and process improvement

ICeBreaker round taBle 3Performance Management Benchmark, Practices and Roadmap

we.conect icebreaKerour Icebreaker session consists of small round tables with speakers, business partners and attendees where the audience will discuss the main challenges and cutting edgetopics of the conference in a relaxed atmosphere. glass in hand, make your way around our round tables and get to know each other. enjoy food and drinks at the opening of the conference, break the ice and get the show on the road.

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CONTENTS

p. 2 | overview speakers main topics

p. 3 | icebreaker Icebreaker session Business partners media partners

p. 4-5 | conference day 1 Challenge your peers evening session

p. 6-7 | conference day 2 world Café

we.CONECT business peerstake advantage of solution-oriented individual meetings that we can arrange with these partners before and during the conference.

BUSINESS PARTNERS

MEDIA PARTNERS

Enterprise System Partnersacorn Business Campus | mahon Industrial park | Blackrock | Corkmr. dermot o‘Callaghanphone: +353 87 832 8905 | email: [email protected]

produCtIvIty management is a felicitous relaunch of the former successful pps management – competence in production and logistics. the concept of produCtIvIty management is characterized by high-value information with long lasting effect, by a close contact to editorial contents in print and on the internet and as well a unique forum, which includes considerable scientists, opinion formers, business practitioners, consultants and analysts for future-orientated trends. www.productivity-management.de

HALFMANN GOETSCH PEITHER AGst. alban-vorstadt 94 | Ch-4052 Basel, switzerlandphone: +41 61 544 00 00 | email: [email protected]




aGendaconference day 1 | monday, 24th septemBer 2012

8.00 | registration with coffee and tea

8.45 | welcome and introduction by we.ConeCt, the Chair and the advisory Board

we.conect strateGy tracKSustainable strategies for improving efficiency, productivity and compliance by implementing comprehensive data- and information platforms9.00 | Case studyFlexible MES Architecture in a changing business environment> general pharma trends: less blockbusters, more specialized drugs, more biotech> past / present: Classical big biotech mes architecture> future: flexible mes architecture to support more and smaller products> special challenges for a contract manufacturer> plans with werum pas-x 3Dr. Bernd Lehle, director Biopharma electronic management systems, Boehringer Ingelheim Pharma GmbH & Co. KG /Germany

9.40 | Case studyChallenges in managing Automation & MES & reducing complexity – don’t Forget the “Human Element” > you’ve invested significantly in automation & control systems > the justification for the expenditure is not being realized > how much was invested in operator influence of the system? > operator training & awareness > Invest in the Culture to realize the improvements expected > Challenges in managing automation & mes & reducing complexity – don’t forget the “human element” Carson Sublett, vice president of operations & site director, DSM Pharmaceuticals / USA

10.20 | refreshment break with networking Zone

we.conect inteGration tracK (1)Bridging the gap between traditional plant floor automation systems and business applications such as Enterprise Resource Planning (ERP), SAP, LIMS, SAP MII, SCM, Track & Trace10.50 | Case studyAdvance from Paper to Process – Leverage MES to Analyze Plant Floor Data for Reporting and KPI Metrics> tactical strategies for implementing control points and an analysis framework to track and trend plant-floor data> transform plant floor data into a strategic analysis tool> tools to track oot / oos and equipment data> how to integrate data into a common database for analysis> Integrating control points in the process to analyze manufacturing data> ways to track and trend ranges and control points> detect anomalies in real-timeTba

11.30 | Case studyMES – Design, implementation, upgrade and gobal rollout (including packaging, warehouse and distribution, interfaced serialised product with MES, ERP and EPCIS systems) @ GenzymePaul Kelly, mes director Corporate operations, Genzyme Industrial Affairs IS / Ireland

12.10 | Case studyImplementing a fully paperless solution involving end to end process integration between MES and ERP, LIMS, asset, and training management systems and standardization on a global level> global mes rollout strategy to minimize project expenses and risks while maximizing resource productivity> standard Integration model aligning business processes across the organization> maintenance of reusable recipe objects and integration data flows across various distinct manufacturing sites> defining the roles and interactions for pat and serialization in the mes realmNirav Patel, manufacturing systems engineer, Bristol-Myers Squibb / USA

12.50 | lunch with networking Zone

we.conect processinG tracK (1)Manufacturing Execution Systems: Technical and organizational requirements and Selection Suitable Systems

14.00 | Case studySoftware-Qualification & Validation from the perspective of Industry – Ensuring high qualitysoftware in the Fast Track environmentJohann Wieser, head automation & mes,F. Hoffmann-La Roche AG / Switzerland

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we.conect compliance & Validation tracK

14.40 | Case studySecurity for Manufacturing – IT Infrastructure and the Cloud Concept – IT Control and ComplianceJens Seest, head of department for Quality assurance It Compliance, LEO Pharma A/S / Denmark

15.20 | Case studyEffective MES implementation – costs, benefits, justification and the people dimension> Identifying the cost drivers in mes projects> Business change and the impact of the people dimension on cost and schedule> hidden benefits – or why the users may come to love the systemDr. Peter Iles-Smith, mes technical director, GlaxoSmithKline plc / UK


we.conect challenGe your peers –what would you do?

In these round tables, each with one moderator, the participants interact, describe & discuss their specific issues, approaches and solutions regarding the conference topic. we.CONECT finds out in advance the most important issues facing the participants.

16.30 | parallel round tablesBased on your input, we will create these Round Tables involving an interactive discussion with your peers.

we.conect processinG tracK (2)Improving Quality & Compliance and increasing Operational Excellence with Manufacturing Execution Systems

17.20 | Case studyTracking of Product Contact Components in sterile manufacture / Traceability of components and management through MES / SAP> Benefits / business case for tracking of components> mes & sap Interface management> tracking of single use parts / tracking of reusable parts> technology, system validation & Compliance > lean manufacturing Quality & regulatory Compliance> factors for successMarian Phelan, sap / mes / material management lead, MSD / Ireland

18.00 | Case studyEnabling Operational Excellence with MES Solutions that Drive Continuous Improvements> leverage mes and machine data to reduce machine change over times> visualize the value chain to reduce lead times> understand how certain tools in mes can be used to increase throughput while maintaining quality> utilize the integration of mes with other systems to reduce inventory and the administrative effort of replenishment John Dzelme, senior systems analyst, Roche Diagnostics / Switzerland

dInner In a relaxed atmosphere to ConClude the fIrst ConferenCe day

20.00 | networking dinner

aGendaconference day 1 | monday, 24th septemBer 2012

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8.40 | welcome and introduction by we.ConeCt, the Chair and the advisory Board

we.conect world caféThe World Café will be initiated with short statements

9.00 | short statement roI Café IDevelop an ROI program for an MES and engage project leaders and stakeholders with long-term goals of their manufacturing execution process > how can we make a truly paperless production a reality in the regulated environment?> what is the best approach to bridge the gap between enterprise systems and the shop floor automation?> high automation / Integration and high flexibility: are these conflicting priorities for an mes implementation? > how does the architecture and system landscape for the future look like > key success factors: who and what do we need to consider for a successful implementation? Dr. Anke Meyer, Business unit director pharma and md&d, Janssen-Cilag AG / Switzerland

9.05 | short statement processing & Integration CaféProcess & Manufacturing IT harmonization of multiple sites to improve product quality and achieve excellence in manufacturing operations> what are the benefits to have harmonized process cross manufacturing sites?> how to understand, identify & manage the differences among facilities?> which are the right strategies & methods to harmonize processes (business) and It?> what are the key challenges during implementation? (data security and validity / language to be used / equipment variation, tolerance differences (ended up with smaller data than desired)Laura Lei, director, global technology, Baxter BioScience / USA

9.10 | short statement training & development CaféTraining through the project lifecycle: > mes awareness training during project initiation (level set expectation and provide your core team with the knowledge they need to scope the project) > mes competency training prior to design (expand the core team and educate smes) > exploratory testing during development (Build a ground swell for your project and educate your future validation testers) > Implementation specific training prior to validation (give your testers the information they need to execute effectively and enable your team to write more generic test scripts) > training for roll-out (design your strategy to meet your organizational needs and available systems – keep focus on key objectives of training and also on defendable compliance positions) Brian Duran, Is project leader, Sanofi Pasteur / France

9.15 | short statement roI Café IISuccessfully Implementing MES: It‘s Not Turn the Key & Go! Saving time and money by ensuring management buy-in from the start> ensuring that mes is seen as a highly useful tool at a facility‘s disposal and not just another technical system > realising that the majority of faults arise from poor management and organisation and not from the technology itself> ensuring consistent communication between operator and management in mes success> evaluating facility-specific priorities in software implementation> how to deal with cultural impact on the organization> Interfacing between erp and mesMarcel de Grutter, head of It portfolio management epo, Abbott Healthcare Products B.V.

9.30 | start world café | each session lasts 40 minuteswe.ConeCt and the chair open the world Café, explaining the principles and set the world Café etiquette.

12.10 | world Café panel discussionPresentation of the key results of the World Café and the individual interviews

12.30 | lunch with networking Zone

aGendaconference day 2 | tuesday, 25th septemBer 2012

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roi café i processing &integration café

training & development café

roi café ii




we.conect inteGration tracK (2)Global & Local Harmonization of MES and related applications & systems

14.00 | Case studyIntegrating GMP production control and business process applications – IT infrastructure design and operation> lean It infrastructure supporting validated and business related processes> design, setup and qualification> manage the operation of mixed gmp and non-gmp environments > security vs. process integration: enable interaction of mes with other systems while not jeopardizing your system integrityStefan Tautscher, global head It, Intercell AG / Austria

14.40 | Case studyMES Implementation to Go-Live at a Greenfield Vaccines and Biologics Manufacturing FacilityMark McKechnie, lead mmdIt / global services, MSD Carlow Site / Ireland


15.50 | Case studyHow a mid-sized company has achieved an additional competitive advantage through the tight integration of their EBR / MES and their Automation System> mes totally integrated with plant automation layer> mes totally paperless> mes integrated with erp> gain in efficiency and saving personnelMichele Vecchi, head of manufacturing Information system, Chiesi Group / Italy

16.30 | Case studySystem Obsolescence – the Road to a New MES / Migration of an MES > 4 years after building a green field fill-finish facility the mes is already obsolete> maintaining ongoing day-to-day manufacturing while migrating to a new mes> Competing for resources with a similar project at the same company but different site> Building the business case migrating a 4 year old systemChristoph Lebl, associate director automation, Genentech Inc., Hillsboro, OR / USA

17.10 | Closing words from the chair and end of the conference

aGendaconference day 2 | tuesday, 25th septemBer 2012

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REFERENCES OF OUR PAST CONFERENCES

“Great event & interactive sessions!“Ben Hopkins, DSM / USA

“Creating new connection!“Marc Labaille, Solvay / France

“Very interesting due to many fields and topics covered!“Dr. Horst Röschert, Ticona GmbH / Germany

“I certainly enjoyed the sections and sessions – top organisation &conference!“Kaveh Pourteymour, BP / UK

“Many thanks to the whole we.conect team, a well prepared andexecuted conference in a new and modern style!“Carsten Schmidt, Siemens Automation / Germany

“Perfect background of participants!“Dr. Wolfgang Rybczynski, SAP / Germany


for more detailed informationaBout our speakers and InteraCtIve segments please vIsIthttp://pharma-mes.we-conect.com

we are lookIng forward to welComIng you!

Documents

MES & Process Minds 2012