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May 2006 Revolutionizing the Cold Chain Volume 206, Number 5 |
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In This Issue · PDA Conference Review · Kodiak Heads To EastPack 2006 · Keep A Watch Out For Kodiak's New R11 · Kodiak Advantages: Value Point #4 More informative. Easier to use. See all of the products in the Kodiak line. How does it work? Trade shows and conferences. Check out past editions. Is there a Kodiak authorized distributor in your region? Want to become one?
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PDA Conference - ReviewIn
the United States, the FDA is the organization that
Mr. Nick Buhay, Acting Director, Division of Manufacturing and Product Quality, Office of compliance, CDER/FDA was one of the speakers on the Session entitled “Global Regulatory Regulations” and all attendees were anxious to see what he had to say about the FDA and shipping regulations.
The key word for shippers is “holding” since Mr. Buhay qualified that the holding of a drug occurs when the drug is being distributed, being transported, or being warehoused for distribution/transport. In summary “holding” is storage which includes transportation. He added that storage of drug products under appropriate conditions is a requirement within CGMP. He then quoted various rules and regulations that justified the FDA position.
Kodiak is perfectly positioned with added value to take advantage of this possibility. Incorporating patented and proprietary technologies, Kodiak offers a comprehensive solution for the movement of temperature sensitive products through the inherently unreliable “cold chain. All of the Kodiak temperature regulated shipping containers have been validated and validation analyses are available and on record. For details on this service, please contact John Howe – COO, Kodiak Thermal Technologies, Inc. at jhowe@kodiaktech.com. To view the full PDA article click on icon below:
For more information regarding the PDA please click the following link: Kodiak Heads To EastPack 2006
Kodiak will have key leadership personnel as well as a knowledgeable sales staff on hand to address any cold chain shipping concerns that you may have. Also, be sure to stop by our booth #4833 in the Medical/Pharmaceutical & Nutraceutical Packaging Pavilion and receive your complimentary free gift. We’ll see you in New York!
For information on EastPack, you may visit them on the web at www.eastpackshow.com
Keep A Watch Out For Kodiak's R11
The
Kodiak R11 is on the way! Keep you eyes open because you don’t want to miss
one. The R11 is the little brother to Kodiak’s flagship R36. It can, will
and does everything that the R36
unit
For more detailed information on the new Kodiak R11 Container, please visit our website at www.GoKodiak.com
Kodiak Advantages: Thermal Regulation Technology Value Point # 4 Rugged Reusable Container
The full line of Kodiak Containers are designed and manufactured as rugged reusable containers for the cold chain shipping industry. The Kodiak Container uses simple packaging that can easily accommodate tamper-evident latches and durable materials which are ecologically friendly.
The
unique design and innovative concept of the containers allow for a full 36
or full 11liters of available cargo space. This provides you with 4 times
more
The Kodiak Container provides added value in a variety of ways. If you would like more information on the full line of Kodiak cold chain shipping containers, please contact Harry Smith, VP Sales & Marketing at (713) 686-1553 ext. 15. To request a Sales Packet please email us at info@kodiaktech.com
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oversees the manufacture
and shipping of pharmaceuticals and biotech products. Within the FDA, the
division charged with this responsibility is the Division of Manufacturing
and Product Quality (DMPQ), Office of Compliance, CDER/FDA.
payload area than standard and traditional disposable containers. All
of the Kodiak Containers are warranted for approximately 100
shipments within 2 year period, which can save hundreds of dollars in
shipping cost compared to disposable containers which have a limited use.