FDA`s enforcement of 21 CFR part 11 compliance 2015

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

• IT Manager and Staff
• Everybody using computers in FDA Regulated Environments
• Regulatory Affairs
• QA Managers and Personnel
• Consultants
• Training Departments
• Validation Specialists