White Papers & eBooks

on 'Facilty Design & Management'

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  • U.S.A. GMPs: What Offshore API Manufacturers Need to Know

    This 341-page PDF outlines a course that Mr. Buhay gave in Beijing last year, summarizing what any manufacturer outside the U.S. should know about GMPs and FDA regulations.

    Nicholas Buhay, Deputy Director of Manufacturing and Product Quality, FDA's CDER
  • A Profile of the Pharmaceutical Manufacturing Industry

    Aiming to develop integrated environmental policies that address the inter-relationships among pollutant releases to air, water and land, in the late 1990s EPA adopted a whole-facility focus. Recognition of the need to develop an industrial “sector-based” approach within the EPA Office of Compliance led to the creation of this document.

    U.S. Environmental Protection Agency
  • Thermal Validation in the Pharmaceutical Industry

    Thermal validation is the process of validating / qualifying equipment and storage facilities to prove that they will create and maintain the temperatures they are designed for. Veriteq Instruments representatives explain why thermistor sensors are more appropriate to most pharmaceutical manufacturing applications than thermocouple sensors.

    Veriteq Instruments
  • 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.
  • 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.
  • 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)
  • 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.
  • 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
  • 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
  • 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
  • Writing a Successful CV or Resume for Biotech

    You’re never too old to revisit the basics. This paper for students, developed by University of California-San Francisco, covers the difference between a CV and a resume, and goes over the fundamentals.

    University of California, San Francisco
  • Don't Say 'Used': How to Select Pre-Owned Equipment

    Buying pre-owned equipment can be risky, but it can also save money and increase production if you know what to look for. Frain Industries' K.C. Christensen offers tips for smart shopping.

    Frain Industries
  • Using a Real Options Approach to Achieve Manufacturing Flexibility

    Good pharmaceutical investment decisions often translate into tremendous profits and market opportunities. Sanofi-Pasteur’s Dr. Guillaume Pfefer and Uriel Kusiatin, principal and co-founder of 2Value Consulting Group, outline new methods for decision-makers to get the most bang for their bucks.

    Guillaume Pfefer, Sanofi-Pasteur, and Uriel Kusiatin, 2Value Consulting Group
  • 21 CFR 11: Risks of Noncompliance

    This paper addresses major concerns about interpretation of the regulation and the ensuing release of "Guidance for Industry: Part 11, Electronic Records; Electronic Signatures - Scope and Application" in August 2003. It also explains FDA's clarification of two points: (1) FDA intends to interpret Part 11 narrowly; and (2) the agency is taking a risk-based approach in enforcing compliance to some of the technical controls for Part 11, such as validation, audit trails, record retention and record copying.

    Master Control
  • Tracking Training in FDA Environments

    Well-managed training programs minimize the risk of noncompliance and enhance product quality. Brian Curran, senior VP of product management and strategic marketing for MasterControl Inc., gives an in-depth look at how drug manufacturers can monitor and optimize employee training.

    MasterControl Inc.
  • Handling MSDSs and Global Hazard Communications

    Do you know all you need to know about global hazard communications and material safety data sheets? Marshall Denhoff of the American Industrial Hygienists Association shares best practices in this article.

    Marshall Denhoff, American Industrial Hygienists Assn.
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