Release Date: 24 March, 2005
Hardcover
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From Book News, Inc.
A consultant to the pharmaceutical industry, Gough offers tools to help people in the industry write effective and concise documentation required by regulations. She addresses such aspects as the specifics of writing documentation for regulatory purposes; organizing and delivering the information; preparing routine reports as well as process, periodic, and progress reports; developing a clear style with strong sentences and correct grammar and punctuation; building a compilation and documentation review system; standardizing formats for easier documentation; and using good documentation practices and control to head off most problems and violations. She focuses mostly but not entirely on the US Food and Drug Administration and on ISO 9000.Book News, Inc.®, Portland, OR--This text refers to an out of print or unavailable edition of this title.
Book Description
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. This book provides writers with the tools they need to put effective documentation in place. It offers a broad range of documents representative of the types of writing in the healthcare industry, from the laboratory and QA to manufacturing and regulatory affairs. The book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.--This text refers to an out of print or unavailable edition of this title. Rating
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