Feb

2003

Part 11 2/03 Changes & Guidance Training Aid$

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The document at the link provided is a SoftwareCPR training aide on Part 11. It provides information and explanation of the Feb 2003 FDA redirection of its Part 11 regulation. It includes a summary of the areas of Part 11 affected, a side by side of the Draft Scope and Application guidance with SoftwareCPR explanation and comments, and the federal register notice withdrawing all . . .

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Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

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3-days onsite with group exercises, quizzes, examples, Q&A.

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Call or email now to schedule a private, in-house class. The fall schedule is filling up!

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Part 11 2/03 Changes & Guidance Training Aid$

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