Temperature-Controlled Pharmaceutical Supply Chain Life Cycle
March 11-14, 2008 | Bethesda, Maryland

Training Course March 11-12

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Conference March 13-14

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Exhibition March 13-14

Download brochure (697 KB) Global members of the pharmaceutical and bio-pharmaceutical industries continue to be faced with evolving regulations and pharmacopeial standards for handling, storing and distributing temperature-controlled products, including those that require controlled room temperature, refrigerated or freezing conditions. The 2008 PDA Pharmaceutical Cold Chain Management Conference and Training Course will bring together industry, regulatory representatives, compendial experts, academicians and solution partners to provide guidance on the distribution of temperature-sensitive pharmaceuticals as it relates to patient safety and product integrity. Plenary sessions will focus on the theme of this year's conference, Temperature-Controlled Pharmaceutical Supply Chain Life Cycle, and will cover topics such as: The global regulatory environment Quality manual Transportation processes Technology transfer processes Implementation of the temperature-controlled pharmaceutical supply chain Cold Chain process validation In addition, members of the PDA Pharmaceutical Cold Chain Interest Group (PCCIG) will discuss the implementation of PDA Technical Report No. 39, 2007 Revision, Cold Chain Guidance for Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment. TR-39 defines the essential principles and practices for the shipment of products which require controlled temperatures during transit and/or storage. This latest revision contains material which was harmonized with input from European colleagues from the Cold Chain Committee (C3) and the Pharma Logistics Forum (PLF). Attendees will also learn how they can influence the future of Cold Chain Management by participating in the activities of the PDA Pharmaceutical Cold Chain Interest Group (PCCIG). Immediately preceding the conference, PDA’s Training and Research Institute will offer a two-day course on Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging Testing and Transport Systems.

Take-Home Benefits

At the completion of this conference, attendees will be able to: Develop a clear understanding of the current global regulatory environment for pharmaceutical materials that require temperature-controlled transport and storage  Understand the critical sections of a Quality Manual and their preparations Establish and control the distribution process Develop and control a Technology Transfer process Implement the temperature-controlled pharmaceutical supply chain Validate a Cold Chain process

Who Should Attend

Department Operations | Regulatory Affairs | Manufacturing | Transportation | Packaging | Quality Assurance/Control Job Function Manufacture of temperature-sensitive materials | Transportation of temperature-sensitive materials | Packaging engineers | Stability coordinators | Supply chain | Logistics | Cold Chain service provider

Contacts

Jason Brown Programs Manager Tel: +1 (301) 656-5900 ext. 131 Fax: +1 (301) 986-0296 Email: brown@pda.org