Mastering and Managing the FDA Maze

Mastering and Managing the FDA Maze

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There is a mountain of information on FDA regulation and compliance for medical device manufacturers. the task is daunting and very few busy manufacturers are regulatory mountain climbers. Reading the regulations provides only a small part of the picture. Understanding what the regulations mean and how compliance can be achieved in your environment is key. Graphic icons organize the text and provide a visual aid to definitions, regulations, procedures, documents, records, and points to remember. Applicable chapters also end with a FDA Investigator Icon, which summarizes what the FDA investigator will expect to see during an investigation.A quality policy, management review and quality audit procedures, quality plan, and quality system procedures and ... FDA understands that such written documentation may be found in the firma#39;s quality manual, design history file (DHF ), anbsp;...

Title:Mastering and Managing the FDA Maze
Author:Gordon Harnack
Publisher:ASQ Quality Press - 1999-01-01


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