Write It Down: Guidance for Preparing Effective and Compliant Documentation by J

Publisher Description

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.

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.

Review

"notable for its readability and its concrete vision: a unique book that marries aspects of science with sharp comment on technical writing in order to provide a community of medical researchers a manual that keeps their specific needs in mind.recommended to all facets of the pharmaceutical community for its clear-sighted direction on how to write for a scientific audience." -Electric Review "a valuable reference for any pharmaceutical/biotech library. It provides the basic foundation and subsequent details to writing effective documents in industry." -Doody's Reviews

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