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View Article  Overheard

The following were overheard at cold-chain events this past summer, and are worth repeating:

"There are three topics on which there will never be agreement: religion, politics and MKT." - conference organizer

"My wife looks great in a little black dress. I could wear that same dress but I would have a hard time justifying why I should." - a cold-chain consultant's regulatory perspective as he explained why one company should be cautious about using another company's ambient temperature profile

"Vacuum panel insulation works much the same was as a Thermos bottle. Inside, it's able to keep hot stuff hot and cold stuff cold. But how does it know?" - a cold-chain educator's introduction to the principles of therodynamics

"There is a lot of crap to consider in the process of choosing a thermal packaging solution. And when I say crap, I mean CRAP: Container, Refrigerant, Ambient temperature exposure, and Pre-conditioning." - cold-chain educator

"I would like to introduce the man who is considered the leading global authority in pharmaceutical cold-chain management and logistics. Unfortunately, he couldn't make it. So, instead please let me introduce you to ____________" - conference host

View Article  PDA Offers Second Chance at Good Cold Chain Managment Training

For those of you who missed the opportunity in March or were turned away because the class was a sell-out; the Parenteral Drug Association Training and Research Institute (PDA-TRI) is once again offering their two day Cold Chain Management Course, Global Regulations and Standards: Influences on Cold Chain Distribution, Packaging, Testing and Transport Systems in conjunction with its annual PDA/FDA Joint Regulatory Conference.

The Training will take place following the joint conference on September 11-12th 2008. Details can be found here.

The course is only offered twice a year in the US and there are a limited amount of seats available.

View Article  Advanced Degrees: Mean Kinetic Temperature - Storage vs. Shipping and the Vagaries of Regulatory Requirements

My regularly scheduled column in Contract Pharma can be read on-line here.

This month, a discussion on MKT, what it is, and what it is not, and whether some companies are playing fast-and-loose with its application to side-step regulatory requirements and short-change their packaging of temperature-sensitive biopharmaceutical products.