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Managing Cold Chain Products Seminar
Wednesday, August 17–Thursday, August 18, 2011
Sheraton Inner Harbor
Baltimore, Md.
Seminar Overview
Healthcare distributors work with manufacturers and service providers daily to store, manage and deliver millions of healthcare products safely and efficiently. With the increasing number of products that require cold chain handling, this seminar will explore how trading partners can effectively manage the distribution of cold chain products to customers while enhancing the safety and security of the healthcare supply chain. Review regulatory considerations and manufacturer expectations for managing cold chain products in the supply chain, and see the latest techniques to properly maintain temperature-sensitive products.
Take advantage of this new HDMA seminar and join your healthcare supply chain trading partners to:
- Hear from the U.S. Food and Drug Administration, including the Agency’s observations, expectations and recommendations for cold chain management;
- Review the nuts and bolts of cold chain management;
- Explore ways to effectively manage the distribution of cold chain products to customers while enhancing the safety and security of the healthcare supply chain;
- Learn about the proper handling of controlled-temperature pharmaceutical products in the last mile of the supply chain;
- Gain practical insights through emerging technology case studies;
- See the latest techniques to properly maintain temperature-sensitive products;
- And much more!
Target Audience
This seminar is specifically designed for healthcare distributors, manufacturers and service providers responsible for managing cold chain products.
Preliminary Program Agenda
11:30 AM–12:30 PM |
Seminar Registration and Luncheon |
12:30 PM–1:00 PM |
Welcome and Seminar Overview
Perry Fri, Senior Vice President, Industry Relations, Membership & Education, HDMA |
1:00 PM–2:00 PM |
Keynote Presentation
Cold Chain Management — Observations, Expectations and Recommendations
The U.S. Food and Drug Administration will kick off the seminar with a presentation on the Agency’s observations, expectations and recommendations for cold chain management.
Speaker: Vipul Dholakia, Interdisciplinary Scientist, MAPCB, Division of Manufacturing and Product Quality, Center for Drug Evaluation and Research, U.S. Food and Drug Administration |
2:00 PM–2:45 PM |
Cold Chain Management 101
What is cold chain and how can improper handling in transit impact the efficacy of the product? Learn about this and much more of the basics in this introduction to cold chain management.
Speaker: David Ulrich, QA Director - Distribution, Abbott Laboratories |
2:45 PM–3:15 PM |
Networking Break |
3:15 PM–4:00 PM |
HDMA Guidelines for Managing Cold Chain and Temperature-Sensitive Products
With the increasing number of products requiring cold chain handling, the HDMA Logistics Operations Committee — comprising logistics and operations professionals from healthcare manufacturers and distributors — developed guidelines for distributing unique cold chain products.
This session reviews HDMA’s recommended guidelines for the storage and transportation of cold chain and frozen healthcare products from the point of receipt by a distributor to the point of delivery to a customer.
Speaker: John Howells, Senior Director, Industry Relations, HDMA |
4:00 PM–5:00 PM |
Pack-Out Process
Learn about the factors affecting cold chain products while in transit. How do season changes impact the pack-out process? Do temperature monitors need to be included with products? Learn how different pack-out options can limit impacts to the product.
Speaker: Chris J. Anderson, Director, Quality and Regulatory Affairs, Cardinal Health, Inc. |
5:00 PM–6:00 PM |
Networking Reception |
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7:30 AM–8:30 AM |
Continental Breakfast |
8:30 AM–9:15 AM |
Managing the Last Mile — PDA Technical Report 46
The Pharmaceutical Cold Chain Interest Group (PCCIG) of the Parenteral Drug Association has produced PDA Technical Report No. 46 Last Mile: Guidance for Good Distribution Practices for Pharmaceutical Products to the End User. Learn how these guidelines can benefit your organization in the proper handling of controlled-temperature pharmaceutical products and devices along the last mile of the supply chain.
Speaker: Chris J. Anderson, Director, Quality and Regulatory Affairs, Cardinal Health, Inc.
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9:15 AM–10:15 AM |
Cold Chain Monitoring Technology and Applications
Hear about cold chain monitoring technology and real-world applications. Learn about the latest trends for emerging technologies and innovative approaches to providing cold chain visibility, improved distribution efficiencies, and regulatory compliance.
Speaker: Jeff Hawkins, Strategic Marketing Manager, Sensitech, Inc. |
10:15 AM–10:30 AM |
Networking Break |
10:30 AM–11:15 AM |
Managing Returns
For cold chain products to remain effective, they must be properly protected throughout supply chain transportation — including the returns process. Explore different issues and methods for managing cold chain product returns.
Speakers: Jerry Schiller, Director of Specialty Distribution, AmerisourceBergen Corporation
Michelle Rich, National Account Manager, American Thermal Instruments |
11:15 AM–11:45 AM |
Standards
Examine differences between the various standards and how they apply to your operations. Learn about proposed changes to USP 1079 Good Storage and Shipping Practices.
Speaker: Kevin O'Donnell, Senior Partner, Exelsius Cold Chain Management – US |
11:45 AM–12:00 PM |
Adjournment |
*Agenda subject to change. |
