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Engineering (R0) eBook Series

Showing 1 - 12 of 12 results
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  • Significant and Nonsignificant Risk Medical Devices

    Edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Thamizharasan Sampath, Indumathy Jagadeeswaran ...
    Series series Engineering (R0)
    This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance ... Read more

    $107.99 USD

  • Medical Device Guidelines and Regulations Handbook

    Edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath ...
    Series series Engineering (R0)
    This comprehensive resource features in-depth discussions of important guidelines and regulations needed to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will ... Read more

    $80.09 USD

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  • Pharmacovigilance Medical Writing

    A Good Practice Guide

    by Justina Orleans-Lindsay ...
    Pharmacovigilance Medical Writing covers the preparation of pharmacovigilance documents for all stages of the drug development process (i.e. from clinical development through to applications for marketing authorisations to the post-marketing stage). For each document, the book presents a review of the regulatory framework that governs the content of the document, followed by practical guidance (e ... Read more

    $51.00 USD

  • Medical Product Regulatory Affairs

    Pharmaceuticals, Diagnostics, Medical Devices

    by John J. Tobin, Gary Walsh ...
    Written in a clear and concise style by an experienced author, this attractively-priced book covers regulatory affairs in all major global markets for pharmaceuticals and medical devices, making it the most comprehensive in its field.Following a look at drug development, complete sections are devoted to national and EU regulatory issues, manufacturing license application and retention, and ... Read more

    $98.00 USD

  • Process Architecture in Biomanufacturing Facility Design

    Edited by Jeffery Odum, Michael C. Flickinger ...
    Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing fieldBiomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical ... Read more

    $160.00 USD

  • Pharmaceutical Microbiology

    Essentials for Quality Assurance and Quality Control

    by Tim Sandle ...
    Pharmaceutical Microbiology: Essentials for Quality Assurance and Quality Control presents that latest information on protecting pharmaceutical and healthcare products from spoilage by microorganisms, and protecting patients and consumers. With both sterile and non-sterile products, the effects can range from discoloration to the potential for fatality. The book provides an overview of the ... Read more

    $188.99 USD

  • Clinical Engineering Handbook

    Edited by Joseph Dyro ...
    As the biomedical engineering field expands throughout the world, clinical engineers play an evermore-important role as translators between the medical, engineering, and business professions. They influence procedure and policy at research facilities, universities, as well as private and government agencies including the Food and Drug Administration and the World Health Organization. The ... Read more

    $170.99 USD

  • Good Design Practices for GMP Pharmaceutical Facilities

    Edited by Terry Jacobs ...
    Series series Drugs and the Pharmaceutical Sciences
    This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical ... Read more

    $70.99 USD

  • Guidelines for Process Safety in Bioprocess Manufacturing Facilities

    by CCPS (Center for Chemical Process Safety) ...
    This book helps advance process safety in a key area of interest. Currently, no literature exists which is solely dedicated to process safety for the bioprocessing industry. There are texts, guidelines, and standards on biosafety at the laboratory level and for industrial hygiene, but no guidelines for large-scale production facilities. In fact, biosafety is largely defined as a field that ... Read more

    $110.00 USD

  • Medical Device

    A Primer Based on Best Practices

    by Rommel Garcia ...
    This book is meant to be a guide to all who want to learn about a highly regulated industry. My approach is to give you, the reader, an example of a fictitious device, and we will take it from a conceptual idea all the way to launch and beyond. My intention is to incorporate the best experiences that I and other contributors have had into this book and convert them into laymans terms for those who ... Read more

    $3.99 USD

  • The Survival Guide to EU Medical Device Regulations

    by Petri Pommelin ...
    The Regulations for medical devices and in vitro diagnostic medical devices were published in the Official Journal of the European Union on 5 May 2017, and they entered into force 26 May 2017. A regulation is a legal act of the European Union that becomes immediately enforceable as law in all Member States simultaneously. This book gives guidance on the definitions, the key concepts and the main ... Read more

    $21.99 USD or Free with Kobo Plus

  • How to Validate a Pharmaceutical Process

    by Steven Ostrove ...
    Series series Expertise in Pharmaceutical Process Technology
    How to Validate a Pharmaceutical Process provides a "how to approach to developing and implementing a sustainable pharmaceutical process validation program. The latest volume in the Expertise in Pharmaceutical Process Technology Series, this book illustrates the methods and reasoning behind processes and protocols. It also addresses practical problems and offers solutions to qualify and validate a ... Read more

    $44.99 USD