Specialist Discussion Forums - Monday, September 20, 2010

Workshop A: Utilizing Continuous Process Improvement to Demonstrate a Risk-Based Approach for Your Temperature-Sensitive Supply Chain

This workshop, will review the benefits offered through integration of traditional enterprise applications (enterprise resource planning ERP, warehouse management systems WMS, and transportation management systems TMS) and cold chain management systems. The session leaders will explore managing a temperature-sensitive supply chain through the application of a risk-based approach.

Banking cold chain data and statistically evaluating supply chain performance over time enables the development of continuous process improvement however traditional solutions have lacked the ability to integrate logistics data housed in other applications.

Integration of logistics data with time and temperature enables efficient analysis of temperature variability by supply chain segment (ground origin, warehouse/cross dock, air, ground destination, warehouse, etc...)

This workshop will explore these key elements together in an interactive and thoughtful discussion linked to specific case studies.

What you will learn:

• Opportunities provided by integrating a cold chain management system with other relevant software applications including (ERP, WMS, and TMS)
• Benefits provided through automated supply chain segmentation analysis of time and temperature data – (integration of logistics data and time and temperature data)
• Opportunities to drive efficiency and reduce costs while meeting regulatory requirements
• The benefits of ongoing monitoring programs and how they support continuous process improvement
• Demonstrate and document compliance with regulatory requirements and standards-based guidance
• Document and mitigate risks through improved Standard Operating Procedures (SOPs)

How you will benefit:
Through case examples and interactive exercises, you will learn how to leverage cold chain data to make informed decisions regarding your cold chain distribution. You will examine:

• Temperature-sensitive risk assessment
• Reduction of quarantine incidents and streamlined approval process
• Statistical evaluation of supply chain processes
• Case study analysis

Your workshop leaders:

Workshop B: Cost Effective Transportation Strategies for 2-30°C Pharmaceutical Products

This workshop will look at how a manufacturer and their lead cold chain solutions provider were able to significantly reduce transportation costs and risks to the manufacturer’s product through close collaboration with the air carrier and freight forwarder. The principles applied in this case study can be applied to any temperature-controlled transportation requirement.

What you will learn:

• How can the temperature of a product be controlled in flight?
• How do you identify and address potential gaps in the transport process
• What role do your providers play in addressing any gaps
• An example of an integrated program that addresses the gaps

How you will benefit:
Through discussions and case scenarios of air transport, you will discuss with your industry colleagues and those experienced with air transport, how to:

• Design a collaborative cold chain process that works in the real world of air transportation
• Anticipate the challenges that threaten your cold chain
• Reduce costs while minimizing risk to the product

Your workshop leader:

John Liebe
Head of Sales for North America
LifeConEx LLC.

Workshop C: Advanced Predictive Simulation Software Technology – Virtual Cold Chain Management

The workshop will facilitate an overview of Advanced Predictive Simulation Software as applied to cold chain transportation shippers. The group will discuss the “As Is” process of iterative physical testing for the design and validation of cold chain shippers. We will also discuss solution options or possible “To Be” process improvements by utilizing simulation software early in the design or selection phase of cold chain shipper configurations.

Through a case study, presented by Ben Romero, Senior Packaging Engineer at Genentech, you will learn firsthand how Genentech is deploying and utilizing predictive simulation software to evaluate shipper performance.

What you will learn:

• Gain insight into how simulation software can assist in the design and validation of Cold Chain Shippers
• 3D Modeling techniques
• Modeling methods use for Phase Change material selection
• Simulate transient thermal profiles
• Decision making factors for evaluating cost-effective transportation systems

How you will benefit:
You will gain an appreciation for the relative costs and benefits of achieving your transportation objectives within the framework of your GDP requirements and discuss how to minimize those costs while maintaining safe transport requirements by utilizing Advanced Predictive Simulation Technology.

• Enhance your ability to select or design cold chain shippers that meet your requirements before testing
• Obtain the knowledge on how to optimize your cold chain shippers to reduce cost and maximize performance
• Increase your understanding of how to effectively work with simulation technology to implement process improvements in your current environment.
• How to mitigate risk associated with transporting temperature sensitive goods

Your workshop leaders:

Workshop D: Environmentally-Friendly Approaches for the Distribution of Temperature-Sensitive Drugs

This workshop will present a wide-ranging overview of environmentallyfriendly packaging designs and distribution methods available for temperature-sensitive pharmaceutical distribution. Evaluation methodologies and economic aspects will be discussed.

What you will learn

• Recycling & Reuse Programs
• Material Considerations and Innovations
• Current Available Products & Their Applications
• Distribution Models
• Carbon Footprint & Life Cycle Analysis
• Waste Management

How you will benefit

• Enhance Your Knowledge of Material Options and Their Environmental Implications
• Learn Ways to Measure Environmental Impact
• Understand How to Analyze Total Program Costs
• Become Better Equipped to Make Smart, Environmentally-Focused Product Decisions

**Workshop open to qualified end-user participants only

Your workshop leaders:

WorkShop E: Performing an Efficient Cold Chain Compliance and Process Gap Analysis

The pharmaceutical cold chain concept implies all necessary means to maintain therapeutic products in the specified manufacturer’s temperature limits during all the logistic and distribution process (manufacture, storage, transportation, final use). The cold chain compliance and process gap analysis is the very first step to allow you to critically evaluate the compliance of your operations, logistics and packaging with regard to the regulatory context and to the security of your products.

What you will learn:

• The regulatory aspects related to the cold chain
• Responsibilities in the supply chain
• Requirements for the storage and handling of drug products
• Packaging, transportation and distribution of drug products
• Performing a gap analysis to know what needs to be done in order to fully comply with regulations and optimize your processes
• Ways and means to develop an executable action plan

How you will benefit:

• Understand how to execute a cold chain regulatory gap analysis
• Discover what should be covered when looking at cold chain compliance
• Gap analysis: The first step to develop a cold chain compliance program
• Uncover the requirements for the storage and distribution of drug products
• Sharing the responsibilities for a good cold chain compliance

Your workshop leaders:

Workshop F: Exploring Best Practices when Implementing Active ULDs and Logistics Processes in a New Trade Lane

Growing your business means reaching more customers in markets that have been historically challenging due to infrastructure, service limitations, and potential risks. In this workshop, you will be presented with proven techniques and best practices that have facilitated increased efficiencies to the transportation plan and packaging system for temperature sensitive products.

What will be covered:

• What are the steps involved in developing a new trade lane and how does they help mitigate risk?
• Do you have an internal “qualification process” for your Transportation Providers?
• What are the advantages of opening up dialogue with all stakeholders in the cold chain?
• Do you have Contingency Planning at each touch point?
• How can we use Post Shipment Analysis so that they provide us with predictable patterns?
• What are we doing with the temperature monitor data? Can it be used to improve the process?

How you will benefit:

• Gain firsthand knowledge about current procedures used to establish a new trade lane for distribution of your temperature sensitive product
• Compare and contrast your method of developing a new temperature sensitive trade lane
• Experience case studies about how a collaborative data management, analysis, and reporting activity can add value to your program objectives

Your workshop leader:

Berkley Stafford
Global Key Account Manager
Envirotainer