Today, Chris Watts, last of the PAT Team leaders to have stayed at FDA, will be leaving the Agency. He has been with FDA for eight years, and plans to return to California, and the San Diego area. Of his stint at the Agency, he writes, "The experience far exceeded my expectations . . . and I can only hope that future opportunities offer as much." Of course, biopharm company recruiters will want to take note that such talent might be available, locally.

At this week's FDA meeting on PAT and QbD, someone in the audience asked CDER Deputy Director Keith Webber, who had spoken about PAT, QbD, process validation (old vs. new) and real time release vs. end of line testing, whether FDA would ever require PAT.

This week, the FDA will lose its most eloquent advocate for process analytical technologies (PAT): Ali Afnan, senior staff fellow at CDER's OPS. who leaves the Agency this Friday to pursue a career in independent consulting. A member of the original PAT team led by Ajaz Hussain, Dr. Afnan had pioneered the use of PAT at AstraZeneca in Europe.

The compliance consultants, Vectech, are now offering virtual cGMP consulting services, to help drug manufacturers deal with FDA compliance questions immediately via videoconferencing. The company is promoting this as a way to eliminate travel costs, yet ensure "face time." Costs are said to be a fraction of what traditional consulting runs. For more, read on.

This week I did some time traveling and was transported back to 2003, during a presentation given at the Bioprocess International conference in Raleigh.

It was a fiine presentation by a well-known professor at MIT. There was just one problem. It’s the identical presentation that we’ve seen again and again for the past six years.

Is it a timeless classic? Yes.