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Write It Down: Guidance for Preparing Effective and Compliant Documentation

Write It Down: Guidance for Preparing Effective and Compliant Documentation

Paperback

Medical ReferenceTechnology & Engineering

ISBN10: 0367393131
ISBN13: 9780367393137
Publisher: Crc Pr Inc
Published: Sep 19 2019
Pages: 504
Weight: 1.30
Height: 1.30 Width: 6.10 Depth: 9.10
Language: English
This book covers writing for the FDA as it applies to the pharmaceutical industry. It presents a brief overview of the regulatory environment and documentation requirements, identifies the roles of writers and readers, and discusses the purpose of good documentation. The book offers documents and representative writing samples from throughout the industry, ranging from the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively. This new edition includes examples of various forms of representation of data and other illustrative materials that accompany documents needed by the FDA.

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