| Day OneJune 14th 2010 |
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| 8:00am |
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Delegate registration and morning refreshments |
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| 9:00am |
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| 9:10am |
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Operational excellence - engaging the workforce throughout the change process
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The effects of refocusing business processes, restructuring and lean programs on the workforce at Novo Nordisk
- Engaging the workforce from top to bottom and across multiple worldwide sites
- Delivering the right competencies to the workforce, aligning communication and establishing transparency to sustain improvements and ensure morale
Jonathan Walker,
Head, cLEAN® Program and Master Black Belt,
Novo Nordisk Pharmaceuticals,
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| 9:45am |
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Supporting the sustainable implementation of operational excellence |
Identifying critical factors that can support or hinder sustainable change
- Overcoming internal inertia within operational excellence initiatives
- Providing a framework for analyzing improvement potential at site level and knowledge exchange opportunities on the manufacturing network level
- Launching corporate OpEx initiatives and making the best use of benchmarking from an organizational development perspective
Dr. Thomas Friedli,
Managing Director, Chair of Production Management,
Institute of Technology Management, University of St. Gallen
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| 10:20am |
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One to one meetings and networking break |
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| 11:40am |
| Manufacturing intelligence workshop |
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Workshop: Achieving the Goals of QbD and PAT – bridging the gap between process development and manufacturing
- Utilising a simple, user-centric interface for direct, on-demand access to all relevant data from disparate sources
- Capturing paper-based data and making it easily available in electronic form
- Sharing data, analysis results and reports across disciplines, scales of operation, and geographically dispersed sites
- Simplifying the preparation and distribution of analysis results
- Automating the generation of periodic reviews and reports of batches and campaigns
Randy Tatlock,
Senior Applications Specialist,
Aegis Analytical Corporation
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| Extending your product lifecycle workshop |
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Workshop: How product stewardship can add value to help extend your product lifecycle while protecting your brand
- Strategies to engage supply chain
- Integrate reuse solutions for customers
- Peaking consumer interest
Holly Gamage,
Vice President,
Heritage Environmental Services
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| 12:15pm |
| Energy and water management workshop |
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Workshop: Maximizing cost reduction while increasing environmental performance: Illustrations
- Maximize cost reduction deploying synergies
- Ensure social success when outsourcing services
- Get the relevant technical expertise to mitigate your operational risks
Jean-Jacques Delobelle,
Pharma Sales Director,
Veolia Environnement
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| Clean air systems workshop |
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Workshop: Hear the latest advancements in clean air solutions for the pharmaceutical industry
Sean O'Reilly,
Air Filtration Segment Specialist, Cleanroom and Bio-Pharma Applications,
Camfil Farr
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| 12:50pm |
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| 2:00pm |
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Breaking operations’ paradigms to unlock value |
- Understand how leading companies are breaking typical operations’ paradigms to drive change beyond historical organizational and functional boundaries
- Examples of specific initiatives showing how companies have taken on this challenge
David Powell,
Partner ,
A.T. Kearney, Inc.
David Hanfland,
Partner,
A.T. Kearney, Inc.
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| 2:45pm |
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Case study: Genentech's continued journey to operational excellence. A bio-manufacturing site's experience |
- Examining the multi-year methodical approach taken to achieve the goals set out at Genentech's bulk biopharmaceutical manufacturing facility in Vacaville, CA
- Hear how the approach has achieved 180 production runs in a row without a loss due to contamination or other processing issues
- Understanding the key initiatives, as well as the integrated partnership between quality, manufacturing, process sciences and facilities personnel
- Analyzing the operational and system improvements made through continued analysis and learning, as well as the deployment of rapid micro techniques to mitigate media contaminations and respond to issues
Robert Lippe,
Director, Manufacturing,
Genentech
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| 3:20pm |
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One to one meetings and networking break |
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| 5:05pm |
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Facilitating and achieving QbD for drug products |
Implementation of QbD / PAT at Novartis and their uses in production
- Incorporation of the QbD principles and PAT applications through the successful re-design of a commercial drug product
- Details on the design space and control strategy for this drug
- The use of MVDA models to ensure quality compliance in routine production
Olivia Darmuzey,
QbD Expert Pharmaceutical Operations,
Novartis Pharma AG
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| 5:40pm |
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Panel discussion |
With the number of new compounds falling over the past decade, there are growing concerns that federal policy and increasing patent challenges contribute to productivity decline. The panel will begin by exploring implications to the question: Do we need to incentivize industry innovation?
Dr. Bob Miller,
Executive Director,
The Shingo Prize for Operational Excellence
Dr. Thomas Friedli,
Managing Director, Chair of Production Management,
Institute of Technology Management, University of St. Gallen
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| 6:20pm |
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Close of day one and networking drinks reception |
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