West Virginia public radio has put together a five-minute report on the feud between Mylan Labs and the Pittsburgh Post-Gazette, including recorded comments from FDA. The crux of the issue: did Post-Gazette reporters "steal" information, or was it handed to them "over the transom." Also at issue is the history of acrimony between the company and the newspaper . . .

Yesterday, we aired a webcast on Lean Six Sigma in pharma. Click here to view. 

Once again, had to miss the best part of this presentation, but did hear Robert Bottone of Genentech discuss the problem that some managers in biopharm and pharma have with Operational Excellence. Many of them still expect “silver bullet’ solutions. This was also a conclusion reached by those who took our recent survey.

Silver bullets simply do not exist, Bottone said. Toyota took nearly 40 years to develop the TPS, so be patient and keep working at it, Bottone suggested. Worthwhile efforts take time.

Decided to ask the panel about error proofing and jidoka and where the industry stands. (For audio of responses, click here). Bottone said that drug manufacturers need to focus on this. William Botha , Director of Operations, Baxter, who will soon publish a book on the subject  of Op Ex(with Wiley) noted the fact that empowering workers is a tough but necessary job. It can’t be done by fiat from a corner office and by patronizing the individual. In addition, he said, operators thrive on challenge. They like it, they need to grow. Fundamental to the whole issue of jidoka and error proofing is respect for the people doing the work. Amen.

BTW, Gwendolyn Galsworth and Martin Hinckley, experts in error proofing and visual systems will be writing regular columns for us on just this topic. This promises to fill a need within pharma and biopharma. Stay tuned.

AMS