Day

July 11, 2000
Failure to have appropriate controls over computer or related systems to assure that changes in records are instituted only by authorized personnel, as required by 21 CFR 211.68(b). For example, see FDA-483 observation 12.
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Upcoming Public Courses

IEC 62304 and Emerging Standards Impacting Medical Device and HealthIT Software training course in Boise, Idaho. 3-Day course.

October 13-15, 2026

Limited Early Bird Registration: $995 / person
Non refundable but transferable.

Or just email training@softwarecpr.com for more info.

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