Colleen C. Sheldon
Key Account Manager- East
Pre-Conference Workshop Day: Tuesday, September 25th 2018
Tuesday, September 25th, 2018
4:15 PM WORKSHOP G: Stability Monitoring & Technology Innovation in the Temperature Controlled Life Science Supply Chain
This workshop will walk through the supply chain, complex as it is, to identify areas to reduce and simplify; while considering new technology to automate. In small breakout discussion stations, you will learn how to manage valuable temperature, shipment and stability data to improve your quality distribution operations; and ultimately provide higher patient safety assurance.
Take a Walk on the Wild Side of Cold Chain. From Origin:
- Global in-transit points and partner sites create disparate sets of data. How can you create a complete picture of product quality in a chaotic global supply chain?
- Working in a cloud-based data management environment across global sites
- *In-practice, in-process breakout discussion:* Collecting, storing, and archiving valuable temperature data in a central database to meet data integrity regulatory requirements
- In-Transit: Managing stability data throughout the supply chain to verify fit for use using a stability budget or establishing an allowable excursion model
- Have you considered all chaotic points? Warehouses and pharmacy refrigerators? What are the possibilities for batch traceability from manufacturer, through the last mile?
- Real-time monitoring vs. using milestones to identity weak points in a lane
- To Destination: USP <1079> and <659> updates and impact to day to day operations including temperature excursion management
- *In-practice, in-process breakout discussion:* In-transit technology and automated processes
- Moving from outdated excursion processing to more automated deviation handling and product release.
- Automation at destination sites: Realistic operational advantages using wireless technology
- *In-practice, in-process breakout discussion: KPIs* Turning data into business intelligence