Discussion on IATA Chapter 17 compliance for temperature-sensitive products at 8th Cold Chain Summit

Pharma IQ, a division of IQPC, announces that Kevin O’Donnell Director & CTA of Tegrant Corporation and Chair of IATA’s Time & Temperature Task Force will discuss compliance with IATA’s revised Chapter 17 at the 8^th Cold Chain Management and Temperature Control Summit.

“Complying with IATA Chapter 17 Revised Regulations and Biopharma Requirements for Temperature-Sensitive Products”

This Summit, being held February 23-25, 2010 at the Westin Harbour Castle in Toronto, ON, aims to strengthen the end-to-end cold chain practices in distribution, packaging, and compliance of temperature-sensitive products.

Kevin brings over 20 years of experience in pharmaceutical supply chain management by moderating the panel discussion “Complying with IATA Chapter 17 Revised Regulations and Biopharma Requirements for Temperature-Sensitive Products” which covers:

• Quality Management Systems requirements (including exception management)
• Processes and responsibilities of all parties, including the shipper, forwarder, ground handlers/transportation service provider, consignee and air carrier
• Storage and warehousing requirements (including temperature mapping)
• Introduction of new time & temperature sensitive handling label usage requirements

Additional panel participants include representatives from Air Canada Cargo and Kuehne + Nagel.

In a recent IQPC Blog Talk Radio Show on cold chain distribution, regulations and the future, Kevin commented: “Five or six years ago, there was virtually no guidance within the industry addressing regulatory compliance for the transport of time- and temperature-sensitive drugs.”

He continues, “Now, through the PCCIG, the PDA is working on drafting documents to help establish some kind of uniformity in guidance for the distribution of all drug products, the primary concern being time- and temperature-sensitive products.”

The 8^th Cold Chain Summit brings together regulatory, industry, and logistics professionals to address critical issues impacting the pharmaceutical supply chain including:

• Allan Reynolds, VP of Industry & Member Relations, Canadian Association for Pharmacy Distribution Management (CAPDM)
• Rafik H. Bishara, PhD, Technical Advisor, Chair, Pharmaceutical Cold Chain Interest Group (PCCIG), Parenteral Drug Association (PDA)
• Barry Rothman, Acting Branch Chief, Manufacturing Assessment & Pre-Approval Branch, US Food & Drug Administration (FDA)
• Sherman Cheung, Director of Supply Chain Management, Sanofi Pasteur
• Gloria Markiewicz, Associate Director, Supply Chain, Novo Nordisk Canada Inc