Write It Down: Guidance for Preparing Documentation that Meets Regulatory Requirements
| Author | : | |
| Rating | : | 4.38 (825 Votes) |
| Asin | : | 1574910884 |
| Format Type | : | paperback |
| Number of Pages | : | 368 Pages |
| Publish Date | : | 2015-05-10 |
| Language | : | English |
DESCRIPTION:
The book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.. 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. 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
"Excellent Resource" according to Jan J.. Makes writing (and constantly reviewing) University policies a much more manageable process. We highly recommend this book if you are in a position where authoring policies and procedures is a requirement.
It provides the basic foundation and subsequent details to writing effective documents in industry." -Doody's Reviews . "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 mindcommended 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