CSafe Utilization in a Quality Management System. Scott Garchar Manager - Global Business Development FedEx Custom Critical

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1 CSafe Utilization in a Quality Management System Scott Garchar Manager - Global Business Development FedEx Custom Critical

2 Agenda CSafe Relationship History Current State Review Quality Management System Summary 2

3 History As the launch customer for CSafe in 2007, FedEx and CSafe have enjoyed a long-standing relationship. The use of the active container allowed FedEx to expand service offerings in the temperature-controlled shipping market. Decades of experience in healthcare transportation (both surface and air) Provided key input with container variant changes Created end-to-end solutions in a Quality Managed environment previously not found in the marketplace 3

4 FedEx Corporation Organizational Chart FedEx provides the efficient access that businesses of all sizes need to succeed $58 billion revenue More than 400,000 team members More than 12 million shipments daily More than 220 countries and territories As of Sept

Temp-Control Progression South Korea FCF Launch First Air Expedite Network Shipment Europe Launch Mexico FedEx Customized Freight (FCF) Launch Brazil FCF Launch

5 Temp-Control Progression South Korea FCF Launch First Air Expedite Network Shipment Europe Launch Mexico FedEx Customized Freight (FCF) Launch Brazil FCF Launch Multi-Country APAC Launch Today First TempAssure Air Shipment Japan FCF Launch CSafe Launch Costa Rica/Panama FCF Launch 5

6 Current State Hub network allows for push / pull efficiencies, speed, increased container utilization, availability and quality management. 6

Quality Management: Critical Parameters for Product Success Product stability Shipping configuration (thermal mass) Product packaging / container Mode of transport / carrier capability Transport

7 Quality Management: Critical Parameters for Product Success Product stability Shipping configuration (thermal mass) Product packaging / container Mode of transport / carrier capability Transport procedures (SOPs) and training / education Temperature profile (environmental stability) Manage ambient along route (in truck and aircraft) Temperature monitoring in near real-time Locations Enable contingency response 7

Education and Training: Foundational Key to Success Product and system integrity start with education Truck and driver procedures Ramp and ground handler procedures

8 Education and Training: Foundational Key to Success Product and system integrity start with education Truck and driver procedures Ramp and ground handler procedures Flight and aircraft procedures Shipper and consignee responsibilities Contingency planning Accountability and audit at each step allow for GDP compliance and support 8

9 Assess Risk: Start With the Environment Air transport environment Normal aircraft temperature main deck (international) Average (ºC) Standard Deviation (ºC) Minimum Temperature (ºC) Maximum Temperature (ºC) Mean Kinetic Temperature (ºC)

10 Best Practice: Manage Ambient Temperature in Aircraft Thermal-mapped FedEx aircraft Containers tested in normal and extreme conditions: Best area to place cargo containers within aircraft Best temperature to help ensure cargo container performs properly 10

Best Practice: Balance Protection and Process to Reduce Risk Truck Transport Risk Factors Ambient conditions / weather Refrigerated truck performance factors Temperature control equipment varies in

11 Best Practice: Balance Protection and Process to Reduce Risk Truck Transport Risk Factors Ambient conditions / weather Refrigerated truck performance factors Temperature control equipment varies in capability to overcome extreme temperatures BTU exchange, TCU settings, Maintenance Route, Schedule, and Preparation Air flow Load/unload environment Cargo preconditioning Monitoring and contingency intervention 11

12 Temperature Loading and Unloading With Cool Temperature Have a plan to handle excursions on the dock and in the truck after loading pull down. Time 12

A Successful Transportation Scenario Includes: An established transport plan Balance product stability, carrier capability (mode) and thermal protection (package) Educated and

13 A Successful Transportation Scenario Includes: An established transport plan Balance product stability, carrier capability (mode) and thermal protection (package) Educated and accountable personnel Use qualified and / or validated equipment Plan for contingency and the environment Monitor strategically Qualified shipping lane(s) verify the process! 13

Summary FedEx has enjoyed a decade-long relationship with CSafe, providing end-to-end Quality- Managed temperature controlled shipping solutions.

14 Summary FedEx has enjoyed a decade-long relationship with CSafe, providing end-to-end Quality- Managed temperature controlled shipping solutions. With standard operating procedures, premium equipment, training and technology in place, customers can rest-assured knowing their product is set-up for transportation success. This allows FedEx to deliver the Purple Promise at each step of the journey. I will make every FedEx experience outstanding. 14

15 Thank You!

Francisco Rizzuto IATA Cargo Manager for Western Europe Specialized in Temperature Controlled Shipments for Pharmaceuticals

Francisco Rizzuto IATA Cargo Manager for Western Europe Specialized in Temperature Controlled Shipments for Pharmaceuticals Pharma Process Forum BCN, October 28 th 205 Q3 205 2 The International Air Cargo