Friday, March 19, 2010

It's Prevnar day

Ladies and gentlemen, thank you for being here tonight. I believe we are here to recognize not only Dr. Graham and myself, but all individuals who summon the faith and courage to challenge unethical
and unlawful practices. I want to share with you the story regarding my attempt to change the dysfunctional regulatory compliance culture of a pharmaceutical manufacturing plant in the years 2000-2002.

- I was hired in 2000 by Wyeth Pharmaceuticals to help in the introduction of Prevnar, a new vaccine designed to fight pneumoccocal pneumonia and meningitis in babies. The North Carolina facility where I worked is the sole production site for this pediatric vaccine which is taken in a four-dose regimen by every infant in the United States at 2, 4, 6, and 12 months. One of my key responsibilities was to assure compliant manufacturing through quality training and continuous improvement systems.

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