Day

October 27, 2003
On 10/23/03, Alan gave a presentation on risk based approaches to Part 11 as recommended in the final FDA guidance.  A copy of the slides are at the link provided. Also available on the site are the slides from Joe Famulare (FDA’s Part 11 lead) presented at this conference. scpred_AKusinitz-Part11AdvamedRiskslides102303
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Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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