Improving Quality & Compliance andincreasing Operational Excellence withManufacturing Execution Systems inPharma & Life Sc...
MES & Process Minds 2012                  24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten                  OVe...
MES & Process Minds 2012                             24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten          ...
MES & Process Minds 2012                  24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten                  aGE...
MES & Process Minds 2012                  24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten                  aGE...
MES & Process Minds 2012                  24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten                  aGE...
MES & Process Minds 2012                  24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten                  aGE...
For more detailed informationabout Our speakers and interactive segmentsplease visithttp://pharma-mes.we-conect.comWe are ...
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Mes & Process Minds 2012 Agenda

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MES & PROCESS MINDS 2012

Improving Quality & Compliance and increasing Operational Excellence with Manufacturing Execution Systems in Pharma & Life Sciences Industries

Life sciences producers are faced with a multitude of new challenges. Economic pressures like globalisation, litigation and government mandated pricing threaten operating margins, while an ever-changing regulatory environment makes it harder to stay compliant. New scientific bases for innovative products increase the complexity of manufacturing. Initiatives, such as targeted treatments and medicine tailored to specific subsets of patients, challenge the industry to change their supply strategy from a classic push-oriented model, to a pull-oriented model, already common in other industries.
In a regulated environment such as the pharmaceutical & Life Science Industry, it is imperative that manufacturing shop floor information is visible in the boardroom on a real time, or near real time basis to enable informed decision-making throughout the supply chain. In addition, MES projects for international markets require new processes for batch records, validation and reporting. The pharma & life sciences industry was the driving force behind many of the concepts of MES, including genealogy, electronic signatures, quality control, specifications, batch execution, paperless batch etc. Of particular importance for this industry is to ensure process quality, efficiency and safety.
Process understanding will be the key to manage these challenges and to build an efficient pharmaceutical production. Manufacturers will have to turn to fully integrated IT solutions to achieve operational excellence.
In this regard Manufacturing IT such as Manufacturing Execution Systems is one of the key business enablers for reaching Operational Excellence. An MES controls, optimizes, and documents business processes executed on the shop floor in full compliance with all the pharmaceutical requirements. It is the goal of an MES to increase security and reliability of the manufacturing process and to improve product quality.
With international Top-Speakers at a senior executive level, the MES & Process Minds 2012 will establish a new approach in finding the right MES excellence strategy for pharma and life sciences industries.

We look forward to welcoming you!

Your we.CONECT team

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Mes & Process Minds 2012 Agenda

  1. 1. Improving Quality & Compliance andincreasing Operational Excellence withManufacturing Execution Systems inPharma & Life Sciences Industries24th – 25th September 2012 | Novotel Berlin Am TiergartenMore THan 15 Case Studies | IceBreaker Session |World CafÉ session | Challenge your Peershttp://pharma-mes.we-conect.com Researched & Developed by
  2. 2. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten OVerview MES & Process Minds 2012 SPeakers Main Topics Dr. Peter Iles-Smith > Strategies and criteria for the selection of MES, MES Technical DIrector - Global Manufacturing & Supply Technical and organisational requirements for GlaxoSmithKline plc / UK MES and selection of appropriate systems > Distributed systems from the perspective of Carson Sublett Vice President Operations & Site Director global harmonisation DSM Pharmaceuticals / The Netherlands > Compliant Documentation, Regulatory Guidance and Quality Assurance for Manufacturing Christoph Lebl Excellence / MES as the bridge to achieve PAT Associate Director Automation and QbD Genentech Inc., Hillsboro, OR / USA > MES Infrastructure for Cloud Computing within a Paul Kelly Regulated Industry / GMP Environment MES Director Corporate Operations > Next generation IT and process control solutions: Genzyme Industrial Affairs IS / Ireland Closing the gap between R&D and manufacturing Dr. Bernd Lehle through intelligent MES Director Biopharma Electronic Management Systems > Review the Value of Early Employee Engagement Boehringer Ingelheim Pharma GmbH & Co. KG / Germany and Training for MES > Cost Management and Effectiveness Analysis for Mark McKechnie MES Projects Lead MMDIT / Global Services > Serialisation Requirements for MES MSD Carlow Site / Ireland > Gradual reduction of IT isolated applications on a Michele Vecchi production level by use of platform solutions Head of Manufacturing Information System > Integration of SAP business systems with Chiesi Group / Italy applications in production control Laura Lei > Integration of SAP MII & SCM Director, Global Technology Group > MES as a comprehensive integration platform: Baxter BioScience / USA With descriptive real-time and detailed information from production, making business processes Stefan Tautscher faster and more flexible Global Head IT > Batch record standardisation: How batch records Intercell AG / Austria were first standardised on paper before going Jens Seest electronic Head of Department for Quality Assurance IT Compliance > MES in Emerging Countries / BRIC - GMP LEO Pharma A/S / Denmark Requirements for Application Dr. Anke Meyer Business Unit Director Pharma and MD&D Janssen-Cilag AG / Switzerland Business PartnerS Mehron Mirian CSV Lead B.Braun Medical Inc. / USA Marcel de Grutter Head of IT Portfolio Management EPO Abbott Healthcare Products B.V. / The Netherlands Marian Phelan SAP / MES / Material Management Lead we.CONECT business peers Merck Sharp & Dohme / Ireland Take advantage of solution-oriented individual meetings that we can arrange with these partners John Dzelme before and during the conference. Senior Systems Analyst Roche Diagnostics / Switzerland Nirav Patel Manufacturing Systems Engineer Travel Partner Bristol-Myers Squibb / USA Johann Wieser Head Automation & MES F. Hoffmann-La Roche AG / Switzerland Brian Duran IS Project Leader Sanofi Pasteur / France Researched & Developed byhttp://pharma-mes.we-conect.com Page 2 / 9
  3. 3. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten aGENDAContents ICEBREAKER Session | Sunday, 23 rd September 2012P. 2 | Overview Speakers we.CONECT ICEBREAKER Main TopicsP. 3 | Icebreaker Our Icebreaker Session consists of small Round Tables with speakers, business partners Icebreaker Session and attendees where the audience will discuss the main challenges and cutting edge Business Partners topics of the conference in a relaxed atmosphere. Glass in hand, make your way aroundP. 4-5 | Conference Day 1 our Round Tables and get to know each other. Enjoy food and drinks at the opening of the Challenge your Peers conference, break the ice and get the show on the road. Evening SessionP. 6-7 | Conference Day 2 World Café 20.00 | Round Tables Pre-conference drinks and Icebreaker Round Tables with speakers, business partners & participants ICEBREAKER Round Table 1 Quality by Design „QbD“ in MES-Concept – How companies deal with QbD, what are their challenges and new proposed approaches from ISPE Mehron Mirian, CSV Lead, B.Braun Medical Inc. / USA ICEBREAKER Round Table 2 Manufacturing Intelligence through coupling BI and process improvement ICEBREAKER Round Table 3 Performance Management Benchmark, Practices and Roadmap Business Partners Enterprise System Partners Acorn Business Campus | Mahon Industrial Park | Blackrock | Cork Mr. Dermot O‘Callaghan Phone: +353 87 832 8905 | Email: dermot.ocallaghan@esp.ie www.EnterpriseSystemPartners.com Make excellent contacts with decision makers to expand your network and generate leads from the best contacts in the business. For further information please visit http://pharma-mes.we-conect.com. we.CONECT business peers Take advantage of solution-oriented individual meetings that we can arrange with these partners before and during the conference. Who participates? Executives of the Board, Managing Directors and Managers from the following departments: > Manufacturing IT / MES > Operations > Data Management > Manufacturing > Manufacturing Business Systems > Plant Management > Technical Services from all Pharma & Biotech > IT Architecture and Development > Automation / Process Automation companies / GMP Manufacturing > Engineering > Process Control / Production Control companies Demographics: Germany, France, The Netherlands, Belgium, UK, Sweden, Norway, Finland, Spain, Ireland, Austria, Switzerland, Hungary, Turkey, USA, Russia Researched & Developed byhttp://pharma-mes.we-conect.com Page 3 / 8
  4. 4. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten aGENDA Conference 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 Track Sustainable strategies for improving efficiency, productivity and compliance by implementing comprehensive data- and information platforms 9.00 | Case Study Flexible 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 3 Dr. Bernd Lehle, Director Biopharma Electronic Management Systems, Boehringer Ingelheim Pharma GmbH & Co. KG / Germany 9.40 | Case Study Challenges 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 & Trace 10.50 | Case Study Advance 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-time Tba 11.30 | Case Study MES – Design, implementation, upgrade and gobal rollout (including packaging, warehouse and distribution, interfaced serialised product with MES, ERP and EPCIS systems) @ Genzyme Paul Kelly, MES Director Corporate Operations, Genzyme Industrial Affairs IS / Ireland 12.10 | Case Study Implementing 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 realm Nirav 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 Study Software-Qualification & Validation from the perspective of Industry – Ensuring high quality software in the Fast Track environment Johann Wieser, Head Automation & MES, F. Hoffmann-La Roche AG / Switzerland Researched & Developed byhttp://pharma-mes.we-conect.com Page 4 / 8
  5. 5. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten aGENDA Conference Day 1 | Monday, 24th September 2012 we.CONECT Compliance & Validation Track 14.40 | Case Study Security for Manufacturing – IT Infrastructure and the Cloud Concept – IT Control and Compliance Jens Seest, Head of Department for Quality Assurance IT Compliance, LEO Pharma A/S / Denmark 15.20 | Case Study Effective 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 system Dr. Peter Iles-Smith, MES Technical Director, GlaxoSmithKline plc / UK 16.00 | Refreshment break with Networking Zone 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 Tables Based 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 Study Tracking 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 success Marian Phelan, SAP / MES / Material Management Lead, MSD / Ireland 18.00 | Case Study Enabling 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 Researched & Developed byhttp://pharma-mes.we-conect.com Page 5 / 8
  6. 6. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten aGENDA Conference Day 2 | Tuesday, 25th September 2012 8.40 | Welcome and introduction by we.CONECT, the Chair and the Advisory Board we.CONECT World Café The World Café will be initiated with short statements 9.00 | Short Statement ROI Café I Develop 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 Café Process & 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 Café Training 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 II Successfully 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 MES Marcel de Grutter, Head of IT Portfolio Management EPO, Abbott Healthcare Products B.V. 9.30 | START WORLD CAFÉ | EACH SESSION LASTS 40 MINUTES we.CONECT and the chair open the World Café, explaining the principles and set the World Café etiquette. ROI Café I Processing & Training & Development ROI Café II Integration Café Café 12.10 | World Café Panel Discussion Presentation of the key results of the World Café and the individual interviews 12.30 | Lunch with Networking Zone Researched & Developed byhttp://pharma-mes.we-conect.com Page 6 / 8
  7. 7. MES & Process Minds 2012 24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten aGENDA Conference Day 2 | Tuesday, 25th September 2012 we.CONECT Integration Track (2) Global & Local Harmonization of MES and related applications & systems 14.00 | Case Study Integrating 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 integrity Stefan Tautscher, Global Head IT, Intercell AG / Austria 14.40 | Case Study MES Implementation to Go-Live at a Greenfield Vaccines and Biologics Manufacturing Facility Mark McKechnie, Lead MMDIT / Global Services, MSD Carlow Site / Ireland 15.20 | Refreshment break with Networking Zone 15.50 | Case Study How 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 personnel Michele Vecchi, Head of Manufacturing Information System, Chiesi Group / Italy 16.30 | Case Study System 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 system Christoph Lebl, Associate Director Automation, Genentech Inc., Hillsboro, OR / USA 17.10 | Closing words from the chair and end of the conference 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 and executed conference in a new and modern style!“ Carsten Schmidt, Siemens Automation / Germany “Perfect background of participants!“ Dr. Wolfgang Rybczynski, SAP / Germany Researched & Developed byhttp://pharma-mes.we-conect.com Page 7 / 8
  8. 8. For more detailed informationabout Our speakers and interactive segmentsplease visithttp://pharma-mes.we-conect.comWe are looking forward to welcoming you! Researched & Developed by

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