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  • Project Management: Know When to Use SOPs, and When Not To

    There is a time and place for standard operating procedures in pharmaceutical projects, but good project management includes knowing when SOPs might do more harm than good.

    Fernando Portes, Principal Project Manager, Best Project Management
  • Taking Drug Packaging to an Art Form

    Why is a new prescription pill bottle on exhibit in a New York gallery? Retailers like Target think it’s the next big thing in drug packaging.

  • If You Blow the Whistle, Are You Protected?

    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 Graham’s criticism of FDA’s oversight of Vioxx.

    John Rouse
  • Big Meeting or Interview? Consult this Checklist for Success

    If you’ve got a job interview or business meeting, sweating the details is essential. Here’s a handy checklist to make sure things go right in the first 30 seconds and beyond.

    JoAnn Hines, Resident Career Expert
  • Leading by Example

    Ajaz Hussain drove the first wave of pharmaceutical PAT from within the FDA. Ironically, he could have even more influence in shaping its second wave now that he’s gone over to “the other side.”

  • PAT in Perspective: Preaching to the Wrong Choir

    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.

    Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
  • Pfizer on Openness, Training and Future PAT Trends

    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 company’s PAT efforts, says PAT leader Steve Hammond. In this interview, he also talks about new training initiatives and shares his view of the future.

  • A New Breed of Leader Shapes Novartis’ Global PAT

    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 company’s global initiative from a manufacturing perspective. In an exclusive interview, he discusses his practical, bottom line-driven approach to PAT.

  • Biopharma Capacity on the Rise

    There’s good and bad news, says BioPlan Associates’ new capacity report. Supply is on the rise, but so is demand. Staffing of operations, equipment and financing are increasing concerns.

    Paul Thomas, Managing Editor
  • All Aboard the Cold Chain

    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.

    Angelo De Palma, Ph.D., Contributing Editor
  • Black Belt Not Required: What’s Your Strategy?

    Moving beyond routine management and fire fighting requires a strategy for business excellence — a strategy based on Six Sigma.

    Penelope Przekop, MSQA, Director, Global Quality Management, Benefit-Risk Management, Johnson & Johnson Pharmaceuticals Group
  • Six Sigma, the Baxter Way

    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 Baxter’s Biologics facility in Hayward, Calif., explains how.

  • Translating Lean from Automotive to Pharma

    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.

    Paul Thomas, Managing Editor
  • Operational Excellence: Straight Talk from BMS’ Wellemeyer

    How does a pharmaceutical manufacturing plant marked for closing transform itself into a corporate model (and home to Pharmaceutical Manufacturing’s 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 Squibb’s Indiana Technical Operations, shares best practices.

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