8:30 -11:30 Workshop A: Addressing Cold Chain Quality for Small Volume Shipments – An Integrated Approach

Ensuring the safe transport of small-volume temperature-controlled shipments presents a unique set of challenges. In this workshop we’ll look at how a manufacturer, packaging provider and logistics company worked together to resolve challenges in transporting high-value, low volume pharmaceutical products internationally.

What you will learn:

Through case studies and open discussion you’ll see how a collaboration among shipper, packaging provider and logistics provider helped reduce product loss and simplify the logistics process for small but high-value pharmaceutical shipments. We’ll discuss the how each party addressed the elements of the logistics process for temperature-sensitive products.

• Relative benefits and limitations of disposable vs. reusable packaging
• How to ensure your logistics provider’s processes are robust and deliver consistent results
• Decision making factors for evaluating cost-effective transportation strategies for cold chain

How you will benefit:

You’ll leave the workshop with some practical steps to ensure that your high-value and temperature sensitive shipments are delivered reliably and consistently. You will understand how one collaboration addressed the real-life obstacles in international transportation.

• Improve the consistency of your temperature controlled shipping results
• Reduce the costs of packaging storage, disposal and transportation
• Improve the efficiency of your logistics operations through packaging standardization and logistics quality.

Your Workshop Leader:
John Liebe
Director of Sales, North America
LifeConEx LLC

8:30 -11:30 Workshop B: Leveraging New Refrigerant Technologies: Use of Engineered Phase Change Materials in Cold Chain Packaging Design

What you will learn:

• Alternatives to traditional gel pack refrigerants available in the industry
• How to identify and evaluate the trade-offs in material costs v. the total costs of the packaging and distribution
• Performance variables to consider in the selection of a PCM

How you will benefit:

• Through case studies interaction with packaging and logistics peers, you will go through examples to understand:
• How traditional water based refrigerants are best utilized and what are their true limitations
• How engineered phase materials can contribute to your company sustainability initiatives
• Re-usability v. Single use? What types of applications are engineered PCM's best deployed?

Your Workshop Leader:
Anthony Alleva
Technical Services Manager
TCP Reliable/Cryopak

12:00 - 3:00 Workshop C: Quality and Efficiency for Cost & Temperature Controlled Transportation

The workshop will facilitate a discussion of considerations for choosing a transportation method, including international regulations, shipping environments, and the strengths and weaknesses of available temperature control options for air and ground transport. The group will discuss solution options and criteria for designing best practice transportation systems and procedures that appropriately blend the needs of your product, your business, and available services. We will also explore the effectiveness of various choices by considering case studies for both ground and air transport.

What you will learn:

• Gain insight into carrier quality systems for both standard transportation and temperature control including:
• Strategies for implementing best practices for achieving high quality and safety in both air and ground transport
• Effective procedures to address transport risk issues
• Decision making factors for evaluating cost-effective transportation strategies for cold chain

How you will benefit:

Through case studies of real-life examples and interactive exercises, you will understand how transport systems can be designed to significantly reduce or eliminate common problems in domestic US and international air transport. 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.

• Improve your ability to implement high quality, secure, and cost-effective transportation
• Enhance your ability to apply industry and governmental guidance on Good Distribution Practices in your transportation plans
• Increase your understanding of how to effectively work with your carrier to maximize the quality, consistency, and economy of your shipping lane

Your Workshop Leader:
Karl Kussow
Manager Quality & Validation
FedEx Custom Critical

12:00 - 3:00 Workshop D: Use of Advanced Predictive Simulation Technology – As Applied to Cold Chain Management

The workshop will facilitate a discussion and hands on with Advanced Predictive Simulation software. The group will discuss the “As Is” process of iterative physical testing for the design and validation of cold chain shippers. The group will also discuss solution options or possible “To Be” process improvements by utilizing Advanced Predictive Simulation Technology early in the design or selection phase of cold chain shipper configurations. Follow a self-paced hands-on tutorial that guides you through the creation process of a simulation model of a cold chain shipper. Apply thermal, flow and phase change boundary condition and solve for a transient solution for a summer profile. Post process 3D result to determine the performance of your design. Review conducting, convection and the performance of the phase change materials over the ambient temperature profile selected.

What you will learn:

Through interactive exercises, you will learn how simulation models of cold chain packaging systems can be quickly constructed. 3D results provide a precise and indepth insight into temperature distribution on all components of the packaging system;

• Create a complex assembly consisting of shipper components, gel packs and product payload
• Define a shipping lane or ambient temperature profile
• Solve a thermal simulation model and review 3D results to understand shipper performance for;
• Conduction
• Convection (passive or active)
• Phase Change
• Environmental Solar Load conditions
• Transient Temperature Profile

How you will benefit:

By utilizing an integrated design & simulation environment, you will be able to;

• Efficient optimization of design concepts & revisions
• Evaluate alternative distribution routing profiles
• Qualify designs for specific ambient temperature profiles
• Reduce the need for iterative physical testing
• Assess impact of temperature excursions during shipment
• Meet or exceed industry quality standards
• Reduced product liability costs

Your Workshop Leader:
Iftekhar Ahmed
Senior Specialist
Cold Chain Management MAYA Simulation Technologies Ltd.

3:30pm - 6:30pm 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 evaluate the compliance of your operations and logistics in regard to the regulatory context and to the security of your products. The respect of the cold chain initially implies to know well constraints which surround it and traps to be avoided.

What you will learn:

• All 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 optimise your processes

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: A 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 leader:

Jean Bédard
Chief Executive Officer
Alternatives Technologie Pharma