The Sarbanes-Oxley Act has added a wrinkle to whistleblower protections first outlined in 1989. This exhaustive
research by Harvard third-year law student John Rouse outlines protections for FDA and private-sector pharmaceutical employees, with a special look at the implications of Dr. David Grahams criticism of FDAs oversight of Vioxx.
Last year at the IFPAC conference, NIR guru Emil Ciurczak bemoaned the fact that PAT was being promoted by geeks for geeks. Now, however, he notes that an upcoming summit may lead the charge toward a new emphasis on convincing corporate and financial managers that PAT simply makes good business sense.
Author: Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
Pfizer has launched an industry-wide initiative to develop open IT interfaces for PAT, and diminished profitability this year has only underscored the importance of the companys PAT efforts, says PAT leader Steve Hammond. In this interview, he also talks about new training initiatives and shares his view of the future.
Typically, Ph.D.s from R&D have led pharmaceutical PAT efforts, and results have been decidedly mixed. At Novartis, process engineer Jim Cheney is driving the companys global initiative from a manufacturing perspective. In an exclusive interview, he discusses his practical, bottom line-driven approach to PAT.
As liability risks increase, drug manufacturers are assuming greater ownership of the cold chain for transporting valuable biologics. Stability testing, data logging and other technologies are helping to ensure product safety as the industry moves toward a whole new distribution model.
Author: Angelo De Palma, Ph.D., Contributing Editor
Baxter Healthcare takes a unique approach to organizational excellence, treating each facility as if it were its own independent small company. Six Sigma has allowed the company to make tremendous strides in productivity. Allen Harmon, director of operations at Baxters Biologics facility in Hayward, Calif., explains how.
Most Lean Manufacturing training uses terminology from discrete manufacturing. The University of Michigan (Ann Arbor) offers courses geared specifically to pharmaceutical manufacturing professionals. Their students are already making a difference at Pfizer, Eli Lilly and other companies.
How does a pharmaceutical manufacturing plant marked for closing transform itself into a corporate model (and home to Pharmaceutical Manufacturings 2005 Team of the Year)? Lean, 5-S and Factory Physics were all important, but people made the real difference. Listen in as John Wellemeyer, director of Bristol-Myers Squibbs Indiana Technical Operations, shares best practices.