FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11 2017

Topics

• How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance?
• What is Data Integrity and how is it implemented
• Validation Master Plan
• Data Integrity Frequently Asked Questions
• Complete Validation for a System (software development lifecycle)
• Risk Based Asssessment
• Infrastructure Requirements
• Automated Test Tools
• SOPs
• Change Control

Who should Attend

Attendees with job titles such as:

• Director of IT
• VP of IT
• Project Managers (for DATA INTEGRITY / IT)
• Quality Managers
• Database Administrators
• Validation Specialists
• Directors / Senior Directors of Discovery
• System Administrators
• Directors / Senior Directors of Development