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Write it Down: Guidance for Preparing Effective and Compliant Documentation, Second Edition
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ISBN
:
9780849321719
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Publisher
:
Informa Healthcare
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Subject
:
Psychology, Research & Information: General, Fiction & Related Items
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Binding
:
HARDCOVER
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Pages
:
479
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Year
:
2005
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31475.0
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30216.0
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Description
This book covers writing for the FDA and other regulators as it applies to the therapeutic product 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 the industry, ranging from the the laboratory to Quality Assurance to manufacturing and regulatory affairs. It provides writers with the tools they need to complete writing tasks effectively.
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