2004 FDA Announces Part 11 Public Meeting June 11

FDA has issued a notice of a public meeting to obtain input on changes to the 21 CFR Part 11 Electronic Records;Electronic Signatures regulation. FDA has published a set of questions on which it is requesting input. The link provided is for the federal register notice announcing the meeting and containing the questions. Comments to be considered for presentation at the meeting are due by May 12, 2004 and comments will be accepted for consideration until July 9, 2004.

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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