Pre-Conference Workshops & Master Course: Monday, July 28, 2008

Please click on the links below to learn more:

Workshop A: Building and Tailoring a Lean Six Sigma Approach for Validation Processes
Workshop B: Leveraging Lean Techniques & Six Sigma to Drive Operation Excellence
Master Course C: Lean Six Sigma Pharmaceutical Process and Product Development
Workshop D: Integrating Lean Six Sigma and PAT Strategies for Operational Excellence
Workshop E: Understanding the Primary Tools and Metrics of Design for Six Sigma (DFSS) and Applications for the Life Science Industry

8:00 am – 11:00 pm Workshop A: Building and Tailoring a Lean Six Sigma Approach for Validation Processes

(Registration 7:45 Breakfast included)

With the issuance of the FDA’s guidance documents defining a more scientifically driven product development and quality paradigm, the philosophy and approach to validation must be revisited. New programs within the FDA such as Process Analytical Technology (PAT) and the Pharmaceutical Quality Assessment System require a much more intensive scientific argument as a premise to validation. One possible solution is to adopt the principles classically utilized within operational excellence approaches such as six-sigma to lay the foundation for a more effective approach to validation and process stability. This workshop will discuss the principles classically employed within validation and process development and describe a new approach that embraces the basic elements of Risk Management and Quality by Design as defined within ICH Q8 and 9 and the ASTM E55 guidance as part of a new approach to Validation.

How you will benefit:

Gaining an understanding of the concepts surrounding the latest FDA guidances pertaining to risk
Understanding the international guidances
Being equipped with the guidances to strengthen and improve your quality framework further
Combining the concepts with the six sigma and lean roadmaps to form an approach which can be used to create a more effective an efficient approach to validation without jeopardizing compliance

What will be covered:

Overview of the Six Sigma and Lean Roadmaps
Overview of ICH Q8, Q9
Validation approaches
Integrated Validation Roadmap

Your workshop Leader:

Bikash Chatterjee
President
Pharmatech Associates

OR

8:00 am – 11:00 pm Workshop B: Leveraging Lean Techniques & Six Sigma to Drive Operation Excellence

(Registration 7:45 Breakfast Included)

How you will benefit:

Learn about operation excellence key building blocks throughout the supply chain and how to analyze their impact on production, QA and QC or other support organization
Be equipped with the needed tools to start making some noticeable improvements in your organization
Learn about the relation between cycle time and OEE / utilization and how to balance between these Key Performance Indicators
Take away practical techniques and tips from the extensive case studies

What will be covered:

Covering the practical tools and key areas for operational excellence throughout the supply chain
Four CASE STUDIES will be presented in the areas of QC, QA and Production: How leveraging Lean Techniques, and Six Sigma, led leading life science companies to achieve operation excellence
Demonstration of Efficiency Management and Continuous Improvement applications to sustain the gains
Conclusion & giving further steps and challenges for operational excellence

Your Workshop Leader:

Rafi Maslaton
President
cResults

11:30 pm – 3:30 pm Master Course C: Lean Six Sigma Pharmaceutical Process and Product Development

Registration 12:15 Lunch will be served

The Life Sciences industries are experiencing a growing need to speed up their processes for developing and transferring new products and processes. This workshop shows how the Lean Six Sigma methodology is used to improve product formulation, manufacturing process development and technology transfer. The goals are to speed up the flow of products through the new product pipeline as well as create high quality and robust products that greatly reduce the problems at product launch. The methods used include Design for Six Sigma and Quality by Design

How you will benefit:

Awareness and understanding of New Product Development and Tech Transfer as a process that can be defined, measured, analyzed, improved and controlled
How Lean Design for Six Sigma concepts, methods and tools can be used to improve the process including case studies and examples
Deployment and culture change needed to support the approach
Answers to your questions regarding New Product and Process Development and Technology Transfer

What will be covered:

• Developing process understanding • Product and process robustness • Streamlining the new product development process • Using pharmaceutical knowledge to enhance the effectiveness of the Lean Six Sigma approach • Strategy for optimizing the large number of variables encountered in product formulation and process development • The role and importance of product and process measurement systems

Your Master Course Leaders:

Ronald D. Snee
Principal and Lean Six Sigma Initiative Leader
Tunnell Consulting

Siddharth Advant
Principal
Tunnell Consulting

4:00 pm – 7:00 pm Workshop D: Integrating Lean Six Sigma and PAT Strategies for Operational Excellence

Registration 4:45 Dinner will be served

Attendees of this workshop will learn how the adoption of the combined approaches of Lean Six Sigma (LSS) and Process Analytical Technology (PAT) and can lead to remarkable results and new ways of working to achieve:

Improved cycle times (more efficient use of current facilities)
Reduced product rejection
More consistent product (improved performance due to consistent assay)
Ease of scale up from laboratory to full scale manufacture
Complete redesign to more effective processing (e.g. continuous processing)

How you will benefit:

Improve time to market, reduce production costs, and improve quality
Reduce your lead time to match your clients’ demands
Handle mass customization and still retain your margins
Facilitate a cultural change towards continuous productivity improvements

Your workshop Leader:

David Vaughn
Senior Lean Six Sigma Consultant
NNE Pharmaplan

Post-Conference Workshop: Wednesday, July 30, 2008

4:00 pm – 7:00 pm Workshop E: Understanding the Primary Tools and Metrics of Design for Six Sigma (DFSS) and Applications for the Life Science Industry

Dinner will be served

How you will benefit:

Getting a solid understanding of the basic tools of DFSS
Learning practical cases of DFSS during the design stage
Learning from other benchmarking industries: Automotive and Semiconductor

What will be covered:

Overview of Quality Assurance and Product/Quality Lifecycle of life science industry
Explain what problems can be solved by DFSS
Dealing with the risks and uncertainties of life science industry
Quality by Design

Your Workshop Leader:

Professor Kai Yang
Wayne State University

Bonus: First 10 Registrations receive a free copy of Amazon best selling book of Design for Six Sigma: Roadmap to product development co-authored by Dr. Kai Yang.

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