Write It Down: Guidance for Preparing Documentation; First Edition

Description: Write It Down: Guidance for Preparing Documentation That Meets Regulatory Requirements; First EditionWritten By: Janet GoughBRAND NEW still in original plastic! About the BookThere is a well understood tenet among the U.S. Food & Drug Administration and otherregulatory bodies: If it isn't written down, it didn't happen! And if it didn't "happen," yourcompany stands to lose a lot of time and money- as well as its competitive edge.Although the need for documentation is readily acknowledged, how to do it appropriatelyand well is another issue altogether. Documentation writing is a critical skill that can beintimidating for many people, particularly because it is so closely scrutinized. How can youensure that the documentation you're writing is not only adequate for the job, butrepresenting you and your company in the best way possible?Write It Down: Guidance for Preparing Documentation That Meets Regulatory Requirementsgives you the tools you need to take the worry out of writing effective and concisedocumentation. Whether you must prepare a report, technical memo, document review, orstudy, this book will help youunderstand the specifics of writing documentation for regulatory purposes;organize and deliver the information;prepare routine reports as well as process, periodic, and progress reports;develop a clear style with strong sentences and correct grammarand punctuation;build a compilation and documentation review system;standardize formats for easier documentation; anduse good documentation practices and control to head off mostproblems and violations.Because there are many types of documentation, this book offers valuable insights intomanaging the system as well as producing documentation that meets the requirements ofboth the FDA and ISO 9000. If your job depends on how you write even one memo, thenthis book is for you.

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Location: Tallahassee, Florida

End Time: 2025-01-22T23:23:50.000Z

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