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

1. Improving Quality & Compliance and
increasing Operational Excellence with
Manufacturing Execution Systems in
Pharma & Life Sciences Industries
24th – 25th September 2012 | Novotel Berlin Am Tiergarten
More THan 15 Case Studies | IceBreaker Session |
World CafÉ session | Challenge your Peers
http://pharma-mes.we-conect.com
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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
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3. MES & Process Minds 2012
24 th – 25 th September 2012 | Novotel Berlin Am Tiergarten
aGENDA
Contents ICEBREAKER Session | Sunday, 23 rd September 2012
P. 2 | Overview
Speakers
we.CONECT ICEBREAKER
Main Topics
P. 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 around
P. 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 Session
P. 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
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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
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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
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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
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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
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8. For more detailed information
about Our speakers and interactive segments
please visit
http://pharma-mes.we-conect.com
We are looking forward to welcoming you!
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