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Write It Down - Guidance for Preparing Effective and Compliant Documentation (Paperback, 2nd edition)
Loot Price: R2,074
Discovery Miles 20 740
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Write It Down - Guidance for Preparing Effective and Compliant Documentation (Paperback, 2nd edition)
Expected to ship within 12 - 19 working days
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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.
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