day one | day two

Day OneJune 14th 2010
08:00
Delegate registration and morning refreshments
09:00
Chairperson's opening remarks
09:10
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
09:45
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
10:20
One to one meetings and networking break
11:40
Operational excellence - engaging the workforce throughout the change process
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,
12:15
Manufacturing intelligence workshop
Aegis
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
 
Cost reduction workshop
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
 
12:50
Networking lunch
14:00
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
14:35
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
15:10
One to one meetings and networking break
16:55
Clean air systems workshop
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
 
Energy and water management workshop
Veolia
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
 
17:30
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
18:10
Close of day one and networking drinks reception

day one | day two

Day TwoJune 15th 2010
08:30
Delegate registration and morning refreshments
08:55
Chairperson's remarks
09:00
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
09:35
Adding value through ‘whole process understanding’
How creative collaborations in process design are enabling companies to get further ahead, faster!
  • Understanding your processes to better inform business decisions
  • Engaging in global collaborations to drive innovative process design
  • Using whole process understanding tools and methodologies to gain competitive advantage
  • Delivering tangible business value though whole process understanding

Sue Fleet, Chief Executive Officer, Britest Limited
10:10
Flexible manufacturing strategies
Using Quality Risk Management to enable flexible multiproduct biotech manufacturing facilities
  • Using QRM to strategic advantage by enabling flexible and progressive facility designs
  • Gaining insight into proven methodologies for multiproduct facility risk assessments
  • Understanding the array of cross-contamination risks associated with multiproduct facilities
  • Strategies for engaging boards of health to facilitate understanding and concurrence with risk-based justification of contemporary facility designs

Kristin Murray, Senior Manager, GCMC Regulatory, Pfizer

Stephen Reich, Risk Management Principal, Global Quality, Pfizer
 
Clearing the regulatory hurdles for continuous manufacturing
Setting up an API continuous manufacturing facility
  • Experiences of FDA and MHRA inspections - gaining approval for this next generation manufacturing process
  • Benefits and pitfalls of continuous manufacturing - lessons learned during the development process
  • Understanding the business case for continuous manufacturing

Peter McDonnell, Senior Technical Director, Genzyme
 
10:45
Networking coffee break
11:45
Anti counterfeiting workshop
Workshop: With the WHO anticipating the conterfeit 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
 
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
 
12:20
Operational excellence
Successfully implement OpEx into the organization
  • Understand the sustainability lessons of The Shingo Prize from 22 years of experience with the best Lean Implementers
  • Discuss the dangers of allowing your lean/operational excellence efforts to become too “tool” oriented
  • Learn the critical relationships between the principles, systems and tools related to Operational Excellence
  • Discover how to organize roles in your company to ensure a sustainable cultural transformation

Bob Miller, Executive Director, The Shingo Prize for Operational Excellence
 
Balancing demand and supply chain solutions
Integrating supply chain and business process management
  • Improving real-time visibility across the enterprise to ensure product quality, improve profitability and response time
  • Eliminating data silos in order to identify unrealized business benefits and minimize risk throughout the production and distribution cycle
  • Facilitating first-in, first-out practice using serialization to prevent costly returns and product loss

Tanya Harris, Executive Director & General Manager, AstraZeneca
 
12:55
Themed luncheon discussions
Discussions include:
12:55
Optimizing the selection of air filters by use of life-cycle cost calculations
Led by:
 
Hear how custom hazardous and non-hazardous waste management prorgams can help address your waste manageent needs
Led by:
 
Develop manufacturing strategies and apply the best business technology solutions to deploy assets, align people and operate day-to-day effectively
Led by: AT Kearney
 
Discover the cost benefits of using recycled plastic pallets to help with your logistical solutions
Lead by: Greystone Logistics
 
14:05
Building a fully flexible manufacturing facility - achieving multi-product production
Understanding the benefits and challenges of investing in a new facility
  • Achieving facility qualification and process validation
  • Managing production of multiple products to maximize productivity and flexibility
  • Minimizing cleaning, switchover and validation times
  • Maximizing return on investment
14:40
Creating the pharmaceutical facility of the future
Panel discussion: Achieving agility in pharmaceutical manufacturing
  • Transforming laboratories and manufacturing facilities
  • Understanding and implementing transformative technologies into new and existing facilities
  • Setting new benchmarks for the future of pharmaceutical manufacturing

Robert Lippe, Director, Manufacturing, Genentech
Peter McDonnell, Senior Technical Director, Genzyme
15:20
Chairperson's closing remarks

day one | day two

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