Topics
- 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
Who should Attend
IT manager and staff, Everybody using computers in FDA regulated environments, Regulatory affairs, QA managers and personnel, Consultants and Training departments.
