Topics
- What are the inspection trends?
- What is FDA`s most current thinking related to computers and electronic records?
- What are the most frequent deviations for computer system validation?
- What are most frequent recent citations for Part11?
- How important is risk based Part11 compliance?
- Under which circumstances can inspectors exercise enforcement discretion?
Who should Attend
Attendees from FDA Regulated Environments, including IT Manager and Staff, FDA Regulated Environments, Regulatory Affairs, QA Managers and Personnel, Consultants, Training Departments and Validation Specialists.
