Management - Pharmaceutical Science Products

  • Clinical Trials Risk Management

    1st Edition

    By Martin Robinson, Simon Cook

    Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs…

    Hardback – 2005-10-12
    CRC Press

  • Facility Validation

    Theory, Practice, and Tools, 1st Edition

    By Graham C. Wrigley

    Often considered a necessary evil by the pharmaceutical industry, validation is still understood by many as unrestrained bureaucracy, paperwork, and procedures whose roots and logic are obscure and only serve to slow down progress. Thoroughly defining the philosophy, application, and processes,…

    Hardback – 2004-03-29
    CRC Press

  • Clinical Studies Management

    A Practical Guide to Success, 1st Edition

    By Simon Cook

    What if you were suddenly in charge? After the initial excitement of a "battlefield promotion" wears off, you need to get in the trenches and get the job done. And if you are already in the trenches, you need quick access to information that will make your job easier. A comprehensive desk reference…

    Hardback – 2004-01-15
    CRC Press

  • Electronic Record Keeping

    Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164, 1st Edition

    By David Nettleton, Janet Gough

    The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic…

    Hardback – 2003-12-29
    CRC Press

  • Filing Patents Online

    A Professional Guide, 1st Edition

    By Sarfaraz K. Niazi

    The average cost of an uncomplicated patent application filing is about $10,000. This high cost can leave thousands of inventors out in the cold. Filing Patents Online: A Professional Guide is a complete manual that walks inventors through each step of filing and prosecuting the patent online at a…

    Paperback – 2003-04-28
    CRC Press

  • Preventing Medication Errors and Improving Drug Therapy Outcomes

    A Management Systems Approach, 1st Edition

    By Charles D. Hepler, Richard Segal

    Read this book in order to learn: Why medicines often fail to produce the desired result and how such failures can be avoided How to think about drug product safety and effectiveness How the main participants in a medications use system can improve outcomes and how professional and personal…

    Hardback – 2003-02-25

  • Pharmaceutical Marketing

    A Practical Guide, 1st Edition

    By Dimitris Dogramatzis

    Designed as a practical guide for the pharmaceutical industry, this book covers how to apply cutting-edge marketing concepts and tools to the real-world intricacies of marketing a heavily regulated product whose success is determined not by the actual end-user, but by various industry stakeholders.…

    Hardback – 2001-10-01
    CRC Press

  • Drug Development Programme Management

    1st Edition

    By Barbara Ann Lead

    This book discusses how program management and related systems and tools can be applied to improve the effectiveness and productivity of drug development and reduce time to market. It explores the roles good experimental design, setting acceptance criteria, teamwork, and problem solving can play in…

    Hardback – 2000-10-31
    CRC Press

  • Continuous Improvement in the Healthcare Manufacturing Industry

    A Practical Guide, 1st Edition

    By Valerie Bland

    Written specifically for the pharmaceutical industry, Continuous Improvement in the Healthcare Manufacturing Industry provides proven methods for cutting costs and improving overall performance according to industry standards. Rather than viewing continuous improvement as a management-led…

    Hardback – 1999-09-30
    CRC Press

  • How to Sell Validatable Equipment to Pharmaceutical Manufacturers

    1st Edition

    By Erik Kopp

    Suppliers of pharmaceutical manufacturing equipment must ensure that their equipment is provided to their customers in a validatable state. Written in simple, clear, and concise language that gets past all the regulationese, this book covers the basics of validation, planning process equipment…

    Hardback – 1999-09-30
    CRC Press

  • How to Develop and Manage Qualification Protocols for FDA Compliance

    1st Edition

    By Phil Cloud

    All current Good Manufacturing Practices (cGMP), Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and ISO 9000 standards and regulations require that validation document be established and followed. Yet these regulations do not provide guidelines on how to produce documentation such…

    Hardback – 1999-08-31
    CRC Press

  • Pharmaceutical Equipment Validation

    The Ultimate Qualification Guidebook, 1st Edition

    By Phil Cloud

    While FDA regulations, cGMP, GLP, GCP, and the industry standard ISO 9000 require that documentation be established and followed, they do not provide guidelines on how to produce that documentation. Pharmaceutical Equipment Validation gives details on how to demonstrate compliance, what data to use…

    Hardback – 1998-08-31
    CRC Press

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