Write It Down: Guidance for Preparing Effective and Compliant Documentation

by Janet Gough

Overview

A well-understood tenet exists among the FDA and other regulatory bodies: if you didn't write it down, it didn't happen. And if it didn't happen, your company stands to lose time, money, and perhaps its competitive edge. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective

Product Details

ISBN-13:	9781040220429
Publisher:	CRC Press
Publication date:	03/30/2005
Sold by:	Barnes & Noble
Format:	eBook
Pages:	504
File size:	3 MB

Table of Contents

Writing Within the Regulated Environment. Connecting Writer and Reader. Organizing and Delivering Information. Correspondence. Policies, Plans, Manuals, Procedures, Methods, and Instructions. Routine Reporting. Process Reports. Summary Reports. Developing a Clear Style. Building Strong Sentences. Managing Verbs in English. Punctuating Effectively. Working on Words. Acronyms, Symbols, and Abbreviations. References.

Editorial Reviews

Reviewer: Thomas Jacobsen, PharmD, MS, RPh, FASCP (ViroPharma Incorporated)
Description: This is a guide on how to prepare effective and compliant documentation in the pharmaceutical industry.
Purpose: The purpose is to help industry professionals explore the hows and whys of preparing effective documents; in addition it provides examples of working documents as well as in-depth explanations of grammar and punctuation.
Audience: This book is written for any pharmaceutical industry professional who is involved in preparing documents. The author has extensive experience as an industry consultant and has taught English at the university level.
Features: It is organized into 14 different sections covering a broad range of information such as writing in a regulated environment, different report types, and writing using effective style/grammar. Of particular interest are the sections on how to develop a clear style and how to build strong sentences. Example documents help the reader visualize what the basic skeletal framework of a particular document looks like.
Assessment: This would be a valuable reference for any pharmaceutical/biotech library. It provides the basic foundation and subsequent details to writing effective documents in industry. This much needed second edition places more emphasis on regulations, the need to document, and the range of documents from discovery to market than the previous edition.

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