Achieving and Maintaining 21 CFR Part 11 Compliance
May 1, 2017
This 1-day seminar reviews the requirements, FDA guidance and industry positions on the Electronic Records & Electronic Signatures rule. The seminar addresses enabling technologies and mechanisms to ensure that the system remains compliant throughout its lifetime. Participants learn how to:
Evaluate new and existing systems for compliance
Complete a Gap Analysis
Prepare a Remediation Plan
The Registration Fee includes attendance, continental breakfast, lunch, and breaks, and an attendee binder containing slides, handouts, and activities.