FDA ADVAMED Part 11 Guidance Presentation

On 10/23/03 Joe Famulare leader of FDA’s Part Redirection committee gave a talk on the final guidance at an Advamed conference. A copy of his slides are at the link provided.

CSV Training Course

Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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