Interesting to see such a diversity of attendees. Most of the usual suspects from Pharma and Biotech are here and participating. The invitation for this particular meeting was extended to partners in cold-chain and they have been actively supporting the cause as well. This is the largest turn-out since the PCCDG was formed some 5 years ago. It feels good to be gaining momentum and receiving recognition for our efforts throughout the industry. It's inevitable then, that these growing pains have forced the group to undertake the process of selecting a "cross-industry"steering committee to oversee the various sub groups that will soon be formed to carry out its vision and mission. The sub groups will have to develop and deliver on proposals to help standardize a laundry list of cold-chain guidance, including testing methodologies, transportation and logistics procedures. As an active member of this organization from the beginning, I have seen a number of eager, well-intentioned volunteers start strong out of the gate only to fade in the homestretchl, due to added workload, added responsibilities and job changes. I hope those who step up realize the time commitment that is required.

The famously fair-haired, and fair-minded director of the PDA-PCCDG, Dr. Rafik Bishara, announced at the top of the meeting of 2 PDA  sponsored events in the coming months. The first is a webinar to be held on February 14th, 2006, "The Role of TR39 In Navigating Today's Cold-Cahin Regulatory Climate". The second is the first PDA Technical Conference on Cold-Chain. That will be held at PDA's offices in Bethesda, MD on March 27-28. Consult the PDA website for more details.

Hugo Weis, (sp?) from the European Cold-Chain Committee C3 is in attendance and has provided valuable input from the European perspective. It appears that the US PCCDG and the EU C3 are, at last, on the verge of a merge - harmonization on their resspective cold-chain guidance documents. More on that tomorrow.

There were a few case study presentations made today, with the one's revolving around trailer mapping and validation garnering lively discussion and debate. Agreement on how to effectively qualify refrigerated trailers remains a contentious issue. This has long alluded the industry and the PCCDG has set its sites on drafting and proposing a standard. Given the data that were presented today, I don't expect agreement will come easily.  This is sorely need - the sooner the better.

Reviewed the draft of the Validation Master Plan guidance document - hammered out in a seesion at Eli Lilly & Company last August. It holds up pretty well - not having looked at it in 5 months. After some minor tweeking, the group hopes to  submit the final draft to the rest of the PCCDG for comment and then it's on to the PDA Science Advisory Board Technical Review Committee for industry comment. If all goes well, publication could be before the end of the year.

I welcome any and all comments on today's events.

And for those of you back east and north who didn't or couldn't make it to San Diego for this event - not to rub it in but... the weather is perfect.