Cold Chain & Logistics Management

Venue: Somerset

Location: Somerset, New Jersey, United States

Event Date/Time: Nov 02, 2010 End Date/Time: Nov 03, 2010
Registration Date: Oct 27, 2010
Early Registration Date: Jul 31, 2010
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Preliminary Outline
An Important Two-Day Conference with Interactive Exercise and Case Studies on:
Regulatory changes and guidance expected in 2010
New Regulations on Storage, Handling and Distribution of Drug Samples & Mail-Order Drugs
Extrapolating Future Regulatory Requirements In-line with Cold Chain Trends
Harmonized Guidance for the Storage and Transport of Temperature Sensitive Therapeutic Products
Understanding Health Canada’s Current and Future Regulatory Expectations
Regulatory Oversight Documents to Create the Matrix as the Backbone of the 27-page Guidance on Good Distribution Practice of Medicinal Products for Human Use
Underlining European Regulatory Expectations for Temperature Sensitive Products
International Focus: Import/Export Shipping Challenges
How to Implement Measurable and Repeatable Cold Chain Logistics Processes
Auditing Cold Chain Capabilities and Qualifying Transportation Equipment
Implementing a Validation Lifecycle Program for Shipping Temperature Control Pharmaceuticals
Implementing Measurable and Repeatable Cold Chain Logistics Processes Using a Core Team Approach
Risk Management for Handling, Storage and Distribution of Temperature-Sensitive Pharmaceuticals & Biologics
U.S. Department of Transportation’s Regulations for Biologics and Biological Agents
Sustaining an Efficient and Compliant Global Biologics Storage and Transport Chain
Transport and Storage of Temperature-Sensitive Drugs and Biologics
Implementing Cold Chain Controls from Manufacturing to Distribution for Cold Chain Pharmaceutical Products
Understanding the Requirements and Operations from the US Customs To Ensure Cargo Security And Supply Chain Integrity
Successful Selection and Implementation of Temperature Controlled Pallet Containers
How to Handle Temperature Exucrsion Incident (Case Study)