Susanne Prokscha

Writing and Managing SOPs for GCP (eBook, PDF)

• Format: PDF

Produktbeschreibung

This book discusses managing SOPs for 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 focused on the practical aspects of SOPs and SOP management.

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 224
• Erscheinungstermin: 29. Juli 2015
• Englisch
• ISBN-13: 9781482239362
• Artikelnr.: 43976002

Autorenporträt

Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She has been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write Practical Guide to Clinical Data Management. She currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups.

Inhaltsangabe

FOUNDING PRINCIPLES. Introduction to SOPs. Document Hierarchies. When to
Have an SOP. What the SOP Should Say. Where to Put the Output. WRITING,
REVIEWING, APPROVING, AND POSTING. Who Writes SOPs? Document A Stable
Process. Mapping a New Process. The SOP Template. SOP Review and Approval.
Posting: Setting Up for Success. MAINTAINING SOPs; MAINTAINING COMPLIANCE.
Deviations from Controlled Procedures. Active SOP Maintenance. HELPING
STAFF FOLLOW SOPs. Finding SOPs. Training on SOPs? Department-Managed
Documents. ADDITIONAL TOPICS. Where to Start. SOPs during Mergers and
Acquisitions. Controlled Glossaries. Example SOP Template. Example SOP of
SOPs.

Rezensionen

"Writing and Managing SOPs for GCP miraculously transforms the boring floss of standard operating procedures into the interesting gold of...SOPs. A reader of this book will find it is hard to imagine managing SOPs without having read the book."
-Norman M. Goldfarb, in Journal of Clinical Research Best Practices, Vol. 12, No. 2, February 2016