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Regulation & Policy

Write it Down

Guidance for Preparing Effective and Compliant Documentation, Second Edition

Publication Date   March 2005
Publisher   CRC Press
Product Type   Book
Pages   504
ISBN Number   0849321719
Product Code   CRC085
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Price £130.00

approximately: $243 | €165

Summary


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.

Content


Writing Within the Regulatory
Environment. Connecting Writer and Reader.
Organizing and Delivering Information.
Writing Letters and Memos.
Preparing Routine Reports.
Process Reports.
Periodic and Progress Reports.
Developing a Clear Style.
Building Strong Sentences.
Verb Tenses in English.
Punctuating Effectively.
Word Usage.