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  • Risk Management, the Right Way

    When risk management techniques are applied to selecting the most appropriate project management organization, the chance of project success soars.

    John Nita and Luiz Correa, Emerson Process Management
  • FDA's Gottlieb Critiques Clinical Trial Design

    In addressing the recent Conference on Adaptive Trial Design in Washington, D.C., Scott Gottlieb, MD, FDA Deputy Commissioner for Medical and Scientific Affairs, applauded recent progress in the evolution of sophisticated drug development tools. However, he also expressed concern over the design of clinical trials and called for a move toward a more adaptive approach.

  • CAPA and Root Cause Analysis

    Recent FDA Warning Letters have cited insufficient corrective and preventive action (CAPA) programs as major compliance weaknesses. How does one ensure one’s CAPA is on the right track? Doug Bartholomew interviews industry QA professionals and leading consultants for the answers.

    Doug Bartholomew, Contributing Editor
  • Economies of Scale for Manufacturing

    Eli Lilly’s process engineering manager Pankaj Mohan shares the technical and management secrets for ensuring the right economy of scale for any pharmaceutical manufacturing process.

    Pankaj Mohan, management leader, global process engineering, Eli Lilly
  • Lutter Briefs House Subcommittee on FDA's Anti-Counterfeiting Action Plan

    Randall W. Lutter, Ph.D., FDA's Associate Commissioner for Policy and Planning, on July 11 addressed the House Committee on Government Reform's Subcommittee on Criminal Justice, Drug Policy, and Human Resources. He reported on the progress — and lack thereof — that FDA and industry have made toward the goals outlined in the Agency's "Combatting Counterfeit Drugs" report.

  • Reading Between the Lines of FDA’s Counterfeit Drug Report

    In June, FDA’s Counterfeit Drug Task Force issued a long-awaited report that signaled the Agency’s current thinking on RFID, drug pedigrees and other issues critical to supply chain security. ABI Research analyst Sara Shah has taken a fine tooth comb to the report, and tells us what FDA is really saying, and what it’s not.

    Sara Shah, Industry Analyst, ABI Research
  • Will Near-Field UHF Be Pharma’s Item-Level Savior?

    Near-field UHF RFID has created a buzz in the drug industry, raising the possibility of an end-to-end UHF-enabled supply chain — which would significantly hold down costs of RFID implementation. Proponents say that the performance of NF could rival high frequency (HF) at the item level. This exclusive excerpt from a recent report by IDTechEx discusses the technology and how it stacks up against HF.

  • 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
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