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  • Waxman Thrusts, FDA Parries, No One Wins

    A June 26 report issued by Rep. Henry Waxman took FDA to task for what it cited as a dramatic decline in enforcement activity during the past five years. The Agency's reply was official yet defensive.

    Heidi Parsons, Managing Editor, Digital Media
  • Silencing the cGMP Priesthood

    cGMPS are essential, but when cGMP dogma triumphs over common sense and prevents innovation, we’re all in trouble, says NIR expert and pharmaceutical industry consultant Emil Ciurczak. He offers some tips for drawing the line between compliance and absurdity.

    Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
  • Mobile Isolators Drive Kentucky’s New Aseptic Facility

    The University of Kentucky College of Pharmacy's new sterile filling facility is a showcase for mobile isolator technology. Could these isolators be used one day in full-scale manufacturing?

    Paul Thomas, Managing Editor
  • Do You Really Understand the Tablet Press Overload Set Point?

    It’s not a critical process or quality parameter, but the right overload set point is essential to the safety of your operators and equipment. Tableting expert Fred Rowley discusses what it can and cannot do.

    Fred Rowley, principal, Solid Dosage Training, Inc.
  • Excerpt from The Light Has Come to Me CD

    "Trouble and ignorance are gone. The light has come to me." In this track from a CD commissioned by the Piramals, one hears an excerpt from the Bhagavad Gita, in English, and music composed to accompany the recitation.

  • Inside E55: Task Groups Go Tête-à-Tête in Toronto

    Engineer and ASTM E55 Recording Secretary Gawayne Mahboubian-Jones provides a member's-eye-view of the issues, initiatives and insights discussed at the Committee's May meeting in Toronto.

    Gawayne Mahboubian-Jones, Director of Engineering, Optimal Industrial Automation
  • PAT in Perspective: Are We Being Spoiled by Success and the Internet?

    NIR expert Emil Ciurczak thinks prosperity and the Internet are making today's graduates far too complacent and out of touch for their own good. Networking and professional societies are at risk, he says, and drug manufacturing will be worse off for it.

    Emil W. Ciurczak, Chief Technical Officer, Cadrai Group
  • Moving Drug Manufacturing from Good to Great

    Pankaj Mohan, U.S.-based management leader for global process engineering at Eli Lilly, shares strategies that can help more drug manufacturers move from good to great.

    Agnes M. Shanley, Editor in Chief
  • PAT and the Crystallization Toolkit

    Process Analytical Technology, CFD and microscopy can help ensure that crystallization scale-up is “right the first time.”

    Des O’Grady, Mark Barrett, Eoin Casey, and Brian Glennon, School of Chemical and Bioprocess Engineering, Center for Synthesis and Chemical Biology, University College Dublin
  • Can North American Manufacturers Thrive in the Challenge of Change?

    Can North American manufacturing be saved or in 10 years is everything going to be made in China? Manufacturers are the front line of the global battle for well-paying jobs and the only ammunition that will help us win this war is acceptance and the embrace of change. To be victorious, our companies need to offer substance and value to their customers and this can only be accomplished by accepting change – now and in the future.

    David Hogg, Association for Manufacturing Excellence
  • Three Keys to Productivity Improvement

    This chapter from Pankaj Mohan's recent book, "Pharmaceutical Operations Management: Manufacturing for Competitive Advantage," discusses productivity improvement, as well as how to achieve results based on an overarching philosophy and three basic elements: knowledge, leadership and "silo-less synergy." Mohan co-authored the book with Gary A. Montague and Jarka Glassey, professors at the University of Newcastle, England.

    Pankaj Mohan, Jarka Glassey and Gary A. Montague
  • Personalized Medicine: Immunotherapy Vaccines

    Named for the natural way its therapies work, with the body’s own processes, a Japanese manufacturer called Green Peptide is focusing on treating cancer and providing patients with a better "quality of life" alternative to chemotherapy or radiation therapy.

    Agnes Shanley, Editor in Chief
  • RFID Battles the Elements

    Metal can be friend or foe. Water is always troubling. And even glass and plastic can impede success. Making RFID work in a pharmaceutical setting takes materials and packaging expertise, and a little black magic. We survey the experts on what they know, and what they don’t.

    Paul Thomas, Managing Editor
  • Cardinal Bets on UHF

    Believe it or not, the success of item-level UHF may depend on shrink-wrapping, says Cardinal’s Renard Jackson.

    Paul Thomas, Managing Editor
  • Pfizer Learns by Doing with RFID

    Pfizer Global Technology packaging expert Tim Marsh takes us through lessons learned on the long road to RFID success.

    Paul Thomas, Managing Editor
  • Think Like an FDA Inspector: Study the Manual

    The best way to understand any FDA inspector's perspectives and what they're looking for when they enter your facility is to study inspections as they do, using FDA's official Investigations Operations Manual. Chapters 5, 7 and 8, on site inspections, recalls and investigations will be especially useful. But even Chapter 1, with official dos and don'ts will offer insights into why inspectors may react or interact with you as they do. A must read, courtesy of FDA's web site.

    U.S. Food and Drug Administration (FDA)
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