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.
Past Events
21 CFR Part 11 Add-On Inspections by the FDA 2014 - 17 Jul 2014, Webinar (21334)
21 CFR Part 11 Add-On Inspections by the FDA 2026
Important
Please, check "21 CFR Part 11 Add-On Inspections by the FDA" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Quality assurance
Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma
Industry: Food & Beverages
Technology: Biotechnology, Information Technology (IT)