day one | day two

Day OneJune 14th 2010
07:30
Delegate registration and morning refreshments
08:30
Chairperson's opening remarks

Dr. Prabir Basu, Executive Director, NIPTE
08:40
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
09:15
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
09:50
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,
10:25
One to one meetings and networking break
11:45
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
12:20
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
 
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
 
12:55
Networking lunch
14:10
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
14:45
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
 
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
 
15:20
One to one meetings and networking break
17:05
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 Apllications, Camfil Farr
 
Energy and water management workshop
Veolia
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
 
17:40
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
18:20
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

Dr. Prabir Basu, Executive Director, NIPTE
09:00
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 3 products to maximise productivity and flexibility
  • Minimising cleaning, switchover and validation times
  • Maximising return on investment

Dr. Thurloch O'Criodain, Head of Quality, Pharma Ops, Novartis Pharma
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
Developing a flexible, multi-product manufacturing strategy
  • Using simulation models to visualize and analyze possible plant performance in order to handle a range of products and demand scenarios
  • Determining how advanced automation, lean initiatives, and flexible manufacturing strategies will effect layout of current and future facilities
  • New approaches to plant design and operation, and the use of new technologies to optimize capacity
 
Quality management
Meeting the regulatory requirements on quality and performance
  • Implementing QbD to meet environmental, health and safety standards while optimizing your total business process
  • Understanding how QbD enables you to react to unexpected changes during processing and still do it right the first time
  • Determining the critical issues related to API and drug product manufacturing using PAT and QbD concepts
 
10:45
Networking coffee break
11:45
Facility management workshop
Workshop: Outsourcing non-core activities - facility management
  • Capitalizing on improved efficiency with greater reliability and reduced waste
  • Optimising plant capability
  • Gain flexibility to increase volume without running the risk of quality loss
 
Quality management workshop
Workshop: Implmenting electronic quality management systems (eQMS)
  • Improve plant-wide performance by integrating activities with real-time information
  • Optimize operations to meet production targets and regulatory demands with error-free consistency
 
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
 
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
14:10
Facilitating the adoption of new technologies and methodologies - PAT and QbD
  • Developing a flexible regulatory process to facilitate the adoption of new technologies and innovative methodologies
  • Resolving challenges to process improvement as a catalyst to creative direction in manufacturing
  • Charting progress to standardize protocols for global initiatives to combat threats to product and patient safety
14:45
Creating the pharmaceutical facility of the future
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
15:20
Chairperson's closing remarks

day one | day two

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