21 CFR Part 11 Add-On Inspections by the FDA 2014 is a webinar that covers topics such as:
- Inspection trends?
- FDA`s most current thinking related to computers and electronic records?
- The most frequent deviations for computer system validation?
- Most frequent recent citations for Part11?
- How important is risk based Part11 compliance?
- Under which circumstances can inspectors exercise enforcement discretion?
- The best strategy for future proven Part 11 compliance
21 CFR Part 11 Add-On Inspections by the FDA 2014 is intended for IT manager and staff, Everybody using computers in FDA regulated environments, Regulatory affairs, QA managers and personnel, Consultants and Training departments.
