| Day OneJune 14th 2010 |
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| 08:00 |
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Delegate registration and morning refreshments |
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| 09:00 |
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Chairperson's opening remarks |
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| 09:10 |
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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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| 09:45 |
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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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| 10:20 |
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One to one meetings and networking break |
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| 11:40 |
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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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| 12:15 |
| 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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| Cost reduction workshop |
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Workshop: Understanding sustainable cost reduction strategies to help you thrive in the industry
- Hear the latest developments of the Environmental Assistence Program (EAP). Hear how waste management programs address the specific needs of the industry and determine a plan to implement the program
Heritage Environmental Services,
Leading Expert,
tbc
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| 12:50 |
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| 14:00 |
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Strategies for environmentally sustainable manufacturing - harnessing the opportunities for cost reduction |
The profitability of sustainability
- Tracking and trending energy consumption to lower operating expense and minimize exposure to fluctuating energy prices
- Developing site specific strategies to reduce excess water use and land-fill waste
- Using MES to drive green initiatives that provide quantifiable competitive advantage
- Assessing the potential of PAT for strategic energy and quality monitoring
James Hagan,
Vice President, Sustainability and Environment,
GlaxoSmithKline
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| 14:35 |
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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 faciilities personnel
- Analayzing 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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| 15:10 |
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One to one meetings and networking break |
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| 16:55 |
| 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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| Energy and water management workshop |
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Workshop: Maximizing cost reduction while increasing environmental performance: illustrations
- Implementing water cycle management solutions
- Utilising alternative energy sources and saving energy throughout production
- Maximising efficiency in use of utilities to reduce costs
Veolia Environment,
Leading Expert,
tbc
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| 17:30 |
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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?
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
Jonathan Walker,
Head, cLEAN® Program and Master Black Belt,
Novo Nordisk Pharmaceuticals,
Olivia Darmuzey,
QbD Expert Pharmaceutical Operations,
Novartis Pharma AG
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| 18:10 |
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Close of day one and networking drinks reception |
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