Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
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  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
Write It Down: Guidance for Preparing Effective and Compliant Documentation

Write It Down: Guidance for Preparing Effective and Compliant Documentation

Gough, Janet

Hardcover

Medical ReferenceTechnology & Engineering

ISBN10: 0849321719
ISBN13: 9780849321719
Publisher: Crc Pr Inc
Published: Mar 1 2005
Pages: 500
Weight: 1.82
Height: 1.24 Width: 6.46 Depth: 9.54
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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