Part 11 Presentation by Paul Motise of FDA

Presentation slides for “Part 11:Electronic Records; Electronic Signatures Answers to Frequently Asked Questions” given by Paul Motise in January of 1999. Paul transferred to the FDA’s Office of Regulatory Affairs from CDER during 1999 and is leading inspector training and enforcement efforts for this rule.

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.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.