| Day OneJune 14th 2010 |
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| 07:30 |
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Delegate registration and morning refreshments |
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| 08:30 |
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| 08:40 |
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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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| 09:15 |
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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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| 09:50 |
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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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| 10:25 |
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One to one meetings and networking break |
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| 11:45 |
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Manufacturing capacity planning in a highly volatile environment; survival techniques, opportunities and risks" |
- As a pre-commercial company, HGSI decided early to build out significant manufacturing infrastructure
- As clinical outcomes were known, we developed a variety of strategies to compensate for both excess capacity and insufficient capacity situations
- The resulting outcome was robust capacity utilization which enabled our systems to develop and attain commercial readiness
- As our products enter the market, we must prepare for additional growth in a manner which avoids undue risk while maintaining cost awareness - the talk will describe the current industry capacity trends and how a producer might take advantage of changes in the market
Curran Simpson,
Senior Vice President, Operations,
Human Genome Sciences
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| 12:20 |
| 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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| Supply chain management workshop |
Workshop: Supply chain optimization - driving operational performance
- Handle uncertainties and global supply chain complexities to reduce inflated inventories while maintaining reliable service levels
- Accelerate value creation and improve collaborative decision-making capabilities with key trading partners
- Drive operational performance through improved planning, risk management, and responsiveness to change
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| 12:55 |
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| 14:10 |
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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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| 14:45 |
| Process improvement and cost reduction |
Using lean principles to continuously improve processes and reduce overall costs
- Reducing batch sizes to cut cycle times and improve responsiveness to customer demand
- Evaluating process flow interruptions to rapidly identify and resolve quality issues ·
- Designing cGMP compliant implementation plans and procedures that optimize layout and support continuous improvement
- Reducing costs of goods throughout the process
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| Anti counterfeiting strategies |
With the WHO anticipating the counterfeit drug trade to reach $75 billion in 2010, what are the best options to protect brand integrity?
- Tools and techniques for safeguarding products and profit margins
- Understanding the limitations of x-ray diffraction, thin layer chromatography, and raman
- Weighing the cost benefit of deploying RFID to prevent tampering and theft
- Developing a layered approach to combat counterfeiting
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| 15:20 |
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One to one meetings and networking break |
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| 17:05 |
| 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 Apllications,
Camfil Farr
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| Energy and water management workshop |
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Workshop: Innovative water and energy management approaches to enhance cost control
- 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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| 17:40 |
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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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| 18:20 |
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Close of day one and networking drinks reception |
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