A01=Janet Gough
Attention Line
Author_Janet Gough
Cap Feeder
Category=CBW
certified
common
Conjunctive Adverbs
contract
Cot
document
Document Management Systems
drug
Electronic Record Keeping
engineer
English grammar for scientists
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eq_dictionaries-language-reference
eq_isMigrated=1
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EQUIPMENT NUMBER
Forced Rat Swim Test
good documentation practices
Independent Clause
Inside Address
Invasive Aspergillosis
laboratory reporting standards
Main Verb
Noun Meaning
organization
Past Tense
pharmaceutical compliance
Prepositional Phrases
Present Perfect
QSIT
quality
Raw Material
regulatory writing
Relative Pronoun Clause
research
scientific correspondence
Size Capsules
SUSAR
Tablet Press
technical
technical writing for regulatory submissions
Total Peak Area
Vice Versa
White Space
Product details
- ISBN 9780849321719
- Weight: 839g
- Dimensions: 156 x 234mm
- Publication Date: 30 Mar 2005
- Publisher: Taylor & Francis Inc
- Publication City/Country: US
- Product Form: Hardback
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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. Write it Down: Guidance for Preparing Effective and Compliant Documentation provides you with the tools you need to put effective documentation in place. The book has a three-pronged focus: to help writers understand the why of what they must write and the current industry standards for good documentation practices, to provide effective examples of a broad spectrum of documents, and to supply an in-depth explanation of grammar and punctuation conventions.
Substantially expanded, the second edition focuses on the regulations, the need to document, and the range of documentation that must be in place to support therapeutic products from discovery through market. Readers will find useful examples of good writing, many provided by people in the industry. Letters and memos; short reports of varied topics, including equipment evaluation, vendor audit, and trip review; standard operating procedures, laboratory methods, and training materials; documentation for an IQ/OQ/PQ project; a journal article; and excerpts from a development report and a dossier are among the many examples. The book also gives a thorough explanation of grammar, punctuation, and usage, with a strong emphasis on the components of the language that pose difficulties for non-native writers of English.
This book is a must for people working in or preparing to work in environments that produce drugs, medical devices, or biologics for sale in countries that have stringent regulatory requirements and where the business language is English. Firmly placing the writing task in context of the existing laws and guidances, the book offers valuable insights into managing systems and producing documentation that meets the requirements of the binding regulations.
Gough, Janet
