Workshop Day

Workshops A & B

Workshop A

8:30 AM Remaining Accountable for Product Integrity through Stability Budgets

Rebecca Gentile, Senior Specialist, Quality, Vaccine and Biological Stability, Merck
Many will argue that the accountability of ensuring product safety and integrity lies with the manufacturer from production to the end point of the supply chain. After all, it is their name on the label. But if that is the case, then where does the responsibility lie once a product changes hands? Supply chain partners must work in tandem to ensure product quality whether it is in their warehouse or downstream. A great first step to this responsibility sharing practice is to generate data to build a detailed stability budget for all products. We will walk you through the stability budget process and how the information can be shared with some customers along the supply chain without sacrificing intellectual property.
What you will Learn:
Build a stability budget to justify investment and improvement in your cold chain operations
Analyzing the trade-offs involved in optimizing different parts of the cold chain
Review the importance of communication between the stability, packaging, and distribution areas within a company to leverage the budget to support a robust supply chain
Streamlining how to use the budget to support the supply chain & communicate and respond to excursions
Address temperature excursions that exceed the time supported in the stability budget: who is responsible, how to communicate, how to determine product disposition
Remain within supported temperature ranges through the supply chain through increase communication


Rebecca Gentile

Senior Specialist, Quality, Vaccine and Biological Stability

Workshop B

8:30 AM Choosing Optimal Packaging to Ensure Product Integrity and Move Towards Sustainability

Dominic Hyde, Managing Director, va-Q-tec Limited
As a green mentality continues to grow across all industries, it is no surprise that the pharmaceutical cold chain is doing their part to remain environmentally responsible. Reusable packaging is the obvious choice to reduce your landfill footprint, but it is not always feasibly. With challenging reverse logistics and a lot of room for error, many companies are opting for other packaging solutions. We will review the benefits of all the choices in packaging to best fit your objectives.
What you will learn:
Address the increased demand for sustainable, more eco-friendly packaging materials
Find a balance between packaging that is both cost effective and meets quality objectives
Decrease your pack-outs by utilizing new technologies
Decide if reusable or single-use packaging is the best fit for your business
Streamline your reverse logistics in the event of recalls, returns, or getting back reusable materials
Manage the temperature profile of your boxes by ensuring they are not validated only under very controlled conditions


Dominic Hyde

Managing Director
va-Q-tec Limited

Workshops C & D

Workshop C

10:45 AM Examining the Science and Data Behind the Passive Solution Selection Process

Lawrence Knorr, Senior Technical Leader, DuPont
In order to specify the most appropriate passive protection for temperature sensitive goods, it’s important to understand the threats the cargo will experience during the full shipping cycle, the fundamental basis of the threat and how it can be addressed, and the response behaviors of the available protection options. The workshop will explore these items in detail.

What you will learn:
·Identify all threats that can occur during the full shipping cycle
·Understand why it’s important to understand the difference between reflectivity and thermal resistance
·How various passive protection options behave in common threat exposure environments, both during the threat exposure, and after being brought back into the cold chain
·Review how the performance behavior can be affected by the measurement location


Lawrence Knorr

Senior Technical Leader

Workshop D

10:45 AM Navigate the Complexities & Cost of Clinical Trial Logistics through Advanced Techniques

Clinical studies in Canada are continuing to grow, but with the country’s unique geography, this is a challenging field. The time and effort spent in defining cold chain logistics on the clinical side is high. The stability studies are not as advanced as commercial and there are not enough products to go around, therefore excursions are not an option. If excursions occur, it is both costly and will slow down the clinical trial process, resulting in slower time to market and increased competition.
What you will learn:
Enable your researchers to utilize progressive approaches to clinical development by meticulously handing their specimens in-transit
Choose the best temperature tracking and PCM materials that can handle both outbound and inbound shipments
Account for the higher costs of shipping clinical products in your overall plans
Enable a sample tracking system that enables samples to be accessioned from lab analysis to the biorepository with verifiable temperature monitoring
Understand the cost and time at risk when delays in clinical shipments occur and trials are postponed

Workshop E

Workshop E

1:00 PM Optimizing Lane Qualification with all Supply Chain Stakeholders in Challenging Shipping Environments

Luiz Barberini, Operations Mng - External Manufacturing Latin America Head, Bayer
Choosing the best shipping lane and external partners for your various product lines while accounting for the various climates & infrastructures encountered is a daunting task. With the variety of product lines increasing and the regions companies are shipping to growing, there are a lot of variables to account for when qualifying your shipments. In particular, Canada’s vast geography and disparate temperature ranges pose a big challenge for logistics professionals. These unique Canadian challenges show direct parallels with the current environment in Brazil. Shipping from South to North Brazil brings about similar road blocks as shipments to remote provinces or the Northern Canadian regions. These issues can be mitigated through smart supply chain management, streamlines logistics, and open communication with supply chain partners.
What you will learn:
• An overview of Brazilian distribution model and its main road blocks
• Examine specific case studies of using streamlined supply chain management to find solutions for the challenging Brazilian infrastructure
• Present a qualifying solution that worked for Brazil into your Canadian & global operations
• Discuss how to establish an evaluation tool to characterize your shipping lanes by riskiness and discuss solutions to decrease that risk
• Review best practices for managing your partner relationships, both local & internationally through use of correct relationship models
• Compare different modes (ocean/air/road) how you can best balance them in your operations, focusing on last mile effect
• Where does lane qualification fit into your overall supply chain management initiatives? How do you prioritize?


Luiz Barberini

Operations Mng - External Manufacturing Latin America Head

Workshop F

Workshop F

3:15 PM Utilizing Historical Data Analysis to Mitigate Risk and Optimize your Global Logistics

Boriana Cavicchia, Senior Program Analyst, Office of Research & Development, Veteran's Affairs Medical Center
Cold chain temperature monitoring generates a large amount of data that can be used to increase efficiency and improve processes. This historical data creates noticeable patterns that can be tracked over time and put towards future improvements. Choosing new shipping lanes for specific products, adapting new technology, or changing transportation modes are all factors that can be adjusted based on spotting the temperature profile trends over time. Empower your team to make more informed decisions through data analytics.
What you will learn:
Meet the increased pressure from regulations and supply chain partners by providing detailed real-time temperature profiles with this data
Work new tracking technology into your processes to increase end-to-end visibility based on what has worked
Discover data logging technology that can increase product integrity and the notification process
Minimize challenges in the last mile by creating a system for retrieving temperature records with downstream partners and across global sites
Discuss the benefits of moving to a cloud-based system and how to ensure data security


Boriana Cavicchia

Senior Program Analyst, Office of Research & Development
Veteran's Affairs Medical Center