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  • Using Open Control to Optimize WFI

    Sanofi-Aventis used S88 and a distributed HMI to automate Water for Injection, boosting efficiency and compliance.

    Agnes Shanley, Editor in Chief
  • S88 Redefines Clean in Place Operations

    Class-based programming simplifies design, testing and validation of reusable modules, such as those found in CIP processes.

    Christie Deitz and Dan Lorenzo, Senior Principal Engineers, Emerson Process Management, and Sean Stephan, Senior Automation Engineer, Biogen Idec
  • The Desired State: PAT and the Road to Enlightenment

    By focusing on the pharmaceutical manufacturing process, ASTM standards for process analytical technology (PAT) promise to bring engineering rigor and proactive decisionmaking to pharmaceutical quality.

    Ajaz S. Hussain, Ph.D., Deputy Director, Office of Pharmaceutical Science, CDER, the U.S. Food and Drug Administration (FDA)
  • PAT Success and Speed Hinge on Data Mining

    Not only data mining but metadata must be considered closely, by a cross-functional team representing all users of that data.

    Julio Pamias, CEO, AtlasBITS, Inc.
  • Stable Isotopes Find a New Role in PAT

    Used to authenticate products, stable-isotopic analysis can also be used to improve process understanding and control.

    John P. Jasper, Robbe C. Lyon and Larry E. Weaner
  • Black Belt Not Required: Do you really know what they want?

    In the words of Dale Carnegie, “You can close more business in two months by becoming interested in other people than you can in two years by trying to get other people interested in you.” Penelope Przekop discusses how to discern and respond to the needs of your internal customers — no matter how difficult they may be.

    Penelope Przekop, MSQA, CQM
  • What Patent Owners Should Consider in Filing for a Patent Term Extension

    The Hatch-Waxman Act clarified distortions in patent extension law, but manufacturers still need to tread carefully when considering the extension process. Heidi Kraus of Sterne, Kessler, Goldstein & Fox discusses the four essential points to keep in mind.

    Heidi L. Kraus, Esq., Sterne, Kessler, Goldstein & Fox P.L.L.C.
  • Maintenance Management Joins the Party

    Pharmaceutical makers pursue more predictive and global technologies to improve output, ensure compliance.

    Doug Bartholomew, Contributing Editor
  • Can 13 Years of FDA Data Teach Us Anything?

    Researchers Jeffrey Macher and Jackson Nickerson are analyzing 13 years of FDA inspection data and reams of documentation to help prioritize inspection risks. We offer their initial findings, presented by Macher at last month’s PDA meeting, as well as the results of Concept Heidelberg’s analysis of 2004 FDA warning letters.

  • Powder Blending From Art to Science

    Predictive models, PAT, and continuous processing promise to reduce variability and improve product quality.

    Angelo De Palma, Ph.D., Contributing Editor
  • Servos Find a Packaging Niche

    Flexibility is driving more manufacturers to servo-driven packaging lines, but concerns remain about validation and the “blue screen of death” with PC-based controls.

    Alan S. Brown, Contributing Editor
  • Career Advice: Get Paid More (Even If You’re Not a Model!)

    Studies by economists show that “above average” looking people tend to earn higher salaries and get promoted more often than those with “average” or “below average” looks.

    JoAnn Hines,'s Resident Career Expert
  • From the Editor: Best Practices or Trade Secrets?

    Security must be a top priority for drug makers, but overly restrictive noncompete and nondisclosure agreements and publishing practices verge on the paranoid – and prevent the exchange of “best practices” that the industry needs in order to improve.

    Agnes Shanley, Editor in Chief
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