2005

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  • The Drug Industry at a Crossroad: PAT's Role

    In this 6-page PDF document, author Efraim Shek asserts that PAT is part of a new paradigm whose time has come, and suggests how PAT can become more the rule than the exception.

    Efraim Shek, Ph.D., Senior Vice President, Pharmaceutical Development, NeuroMolecular Pharmaceuticals, Inc.
    12/21/2005
  • Recommendations on Auto ID for Medical Devices

    With barcoding and RFID recommendations less clear for the device industry, FDA contracted the nonprofit group ECRI to survey the broad Auto ID landscape. This paper details ECRI's findings.

    ECRI
    12/07/2005
  • Aseptic PAT and Particle Monitoring — from Snapshots to Continuous Feedback

    Particle monitoring is critical for maintaining aseptic conditions, but portable counters won’t help develop trending data. In this white paper, Mark Hallworth, pharmaceutical manager for Particle Measuring Systems, discusses continuous monitoring methods, how they’re evolving, and why they’re important.

    Mark Hallworth, pharmaceutical manager, Particle Measuring Systems
    11/22/2005
  • On-Line Alarm Auditing: A Tool for Greater Efficiency

    The right alarm auditing tool can tell you where opportunities for improvement are, and what the payback might be, explains Machine Automation, Inc.’s Brian Gibson.

    Brian Gibson, P. Eng., Machine Automation, Inc.
    11/08/2005
  • Pitfalls of Doing Back-of-the-Envelope Calculations to Determine OEE

    Many manufacturers do not have a handle on their plants' true efficiency. By taking a strict approach to calculating Overall Equipment Effectiveness (OEE), companies can identify all sources of lost time and lost production. In this paper, engineers from Parsec Automation Corp. illuminate how to calculate OEE accurately.

    Parsec Automation Corp.
    11/03/2005
  • How to Implement an Infrared Plant Maintenance Program

    Thermal imaging is a critical part of plant maintenance program. Fluke Corp., which owns Raytec and recently added Infrared Solutions to its product line, offers start-up tips and integration solutions.

    Fluke Corp.
    11/03/2005
  • Monitor Fermentation O2 and CO2 in Real Time

    Keeping tabs on oxygen and carbon dioxide content in bioprocesses is critical for safety and contamination control, while comparing measurements against process models can help optimize yields and efficiencies, explains Tim Wilkes of Servomex, Inc.

    Tim Wilkes, Servomex, Inc.
    10/31/2005
  • The Importance of Online Analysis in Solvent Recovery

    As commercial and regulatory pressures increase, manufacturers look to maximize solvent recovery through online analysis. Tim Wilkes of Servomex, Inc. discusses the benefits.

    Tim Wilkes, Servomex, Inc.
    10/31/2005
  • Whistleblower Protections for FDA and Private-Sector Employees

    This paper discusses the whistleblower protection laws that impact both the FDA and publicly traded pharmaceutical companies. The author outlines how and why the Sarbanes-Oxley act applies to drug manufacturers, analyzes the Act’s statutory language, and explores the procedures by which one would bring a Sarbanes-Oxley whistleblower claim.

    John Rouse (a third-year law student)
    10/28/2005
  • Improve Safety through Leadership, from Top to Bottom

    What makes a leader effective at improving and influencing safety? How can such leaders be cultivated throughout the organization? Thomas Krause, Ph.D., of Behavioral Science Technology, has the answers.

    Thomas Krause, Ph.D., Behavioral Science Technology, Inc.
    10/21/2005
  • The Next Wave in Disposable Mixing

    Disposable mixers have expanded their repertoire and can now handle high-viscosity solid/liquid mixing. Wave Biotech maps out the throwaway future.

    Wave Biotech
    10/18/2005
  • Biotechnology in the Islamic Republic of Iran

    This 518 KB PDF (converted from a PowerPoint presentation by United Nations officials) provides an overview of the current state of biotechnology R&D capabilities in Iran.

    United Nations
    10/11/2005
  • Assessing the Economic Contributions of Foreign Graduate Students

    Foreign graduate students have always played a critical role in spurring innovation and economic growth in the U.S. In this white paper, an economics professor from University of Colorado (Boulder) and colleagues from the World Bank examine their contributions in greater detail, and consider the impact that post-9/11 immigration policies may have on U.S. technology.

    Keith E. Maskus, Department of Economics, University of Colorado at Boulder; and G. Chellaraj and A. Mattoo, World Bank
    10/06/2005
  • Tapping the U.S. Workforce's Potential

    In order to realize its workforce's untapped potential, the U.S. needs to overhaul the way it teaches science and engineering, and to communicate the benefits of these fields to the young. This white paper from the Business Roundtable outlines an ambitious challenge for U.S. government and industry: double the number of students in the U.S. seeking B.S. and graduate degrees in science and engineering over the next 10 years.

    A consortium of business and industry associations
    10/06/2005
  • PAT and Pharma Competence

    This Guide to Process Analytical Technology analyzes the industry’s needs and discusses Siemens' multidisciplinary approach to meeting them.

    Siemens AG
    09/30/2005
  • MVA Modeling without Tears

    So your operators wouldn’t know a differential from a quadratic equation? Curvaceous Software’s C:Suite Process Modeler uses geometric process control to handle quality control, process control and alarm management. Founder Robin Brooks and his colleagues discuss how it works, in an article originally published by IEEE.

    Robin Brooks, Curvaceous Software
    09/30/2005
  • Secrets to Finding a Job in a Tough Market

    Ignore those who say to keep your resume short. Don’t state your individual goals. Job search specialists Challenger, Gray & Christmas have found that following “the conventional wisdom” may not yield the best results.

    John Challenger, CEO, Challenger, Gray & Christmas
    09/23/2005
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