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      Book

      Writing and Managing SOPs for GCP
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      Book

      Writing and Managing SOPs for GCP

      DOI link for Writing and Managing SOPs for GCP

      Writing and Managing SOPs for GCP book

      Writing and Managing SOPs for GCP

      DOI link for Writing and Managing SOPs for GCP

      Writing and Managing SOPs for GCP book

      BySusanne Prokscha
      Edition 1st Edition
      First Published 2015
      eBook Published 23 July 2015
      Pub. Location Boca Raton
      Imprint CRC Press
      DOI https://doi.org/10.1201/b18694
      Pages 224
      eBook ISBN 9780429156465
      Subjects Bioscience, Computer Science
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      Prokscha, S. (2015). Writing and Managing SOPs for GCP (1st ed.). CRC Press. https://doi.org/10.1201/b18694

      ABSTRACT

      Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user's point of view to keep topics focus

      TABLE OF CONTENTS

      chapter 1|6 pages

      Introduction to SOPs

      chapter 2|16 pages

      Document hierarchies

      chapter 3|6 pages

      When to have an SOP

      chapter 4|8 pages

      What the SOP should say

      chapter 5|10 pages

      Where to put the output

      chapter 6|4 pages

      Who writes SOPs?

      chapter 7|8 pages

      Document a stable process

      chapter 8|10 pages

      Mapping a new process

      chapter 9|20 pages

      The SOP template

      chapter 10|14 pages

      SOP review and approval

      chapter 11|12 pages

      Posting: Setting up for success

      chapter 12|10 pages

      Deviations from controlled procedures

      chapter 13|16 pages

      Active SOP maintenance

      chapter 14|6 pages

      Finding SOPs

      chapter 15|12 pages

      Training on SOPs

      chapter 16|12 pages

      Department-managed documents

      chapter 17|6 pages

      Where to start

      chapter 18|6 pages

      SOPs during mergers and acquisitions

      chapter 19|6 pages

      Controlled glossaries

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