Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

Did any of you catch that recent WSJ report on the negative impact of mass layoffs? OK, I know that M&A layoffs are different, but today brought the sad news that Pfizer/Wyeth will lay off 6,000 employees and close eight of its manufacturing plants in Ireland, Puerto Rico and the U.S.

Want to make yourself indispensible, within pharma or other industries?  This just in from Quality Digest.

AMS

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.

From the Wharton business school, an interesting piece on an easy way to motivate employees...connect them to those who benefit from their work. Professor Adam Grant has tested this theory and found it works....I'm betting that plant accidents or quality problems wouldn't happen  as frequently if employees had regular contact, of some sort, with the end users of the products they make.  For more, read on.

AMS

Recent postings in the WSJ blog and elsewhere have asked the troubling question: Does Lean Manufacturing, by definition, lead to quality control problems? Click here for an interesting read. (For something that doesn't require registration, click here.)

Everyone keeps talking about how the industry is on the brink of great change….it’s the death of the blockbuster….the birth of…what?  The niche-buster? Personalized medicine? 

Just keeping up and fire-fighting may be difficult enough so it is tempting to be like Scarlet O’Hara, as in “we’ll just deal with those issues tomorrow.” 

I've always found one of the most evocative terms in the Toyota lexicon to be “gemba” ----the real place, or as it has more poetically been translated, “the place where truth will be found.”  The word already implies that you may have preconceived notions of what the truth is and need a reality check. What better way to define the workplace, whether that's a laboratory or a factory?

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.