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.

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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