The FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11 2017 is a seminar that covers topics such as:
- 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
The FDA Data Integrity for Computerized Systems: Combat the Misconceptions of 21 CFR 11 & Annex 11 2017 brings together 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