Seminar on FDA Data Integrity for Computerized Systems in Mumbai 2017

his Hands-On course will provide the attendees with more detailed experience on validation / 21 CFR 11 compliance of a computer system, as well as details for activities associated with computer systems validation as follows: 1. What is Data Integrity and how is it implemented 2. How to use Risk Based Assessments to reduce work while still achieving Data Integrity and Compliance? 3. Data Integrity Frequently Asked Questions 4. Validation Master Plan 5. Risk Based Assessment 6. Complete Validation for a System (software development lifecycle) 7. Automated Test Tools 8. Infrastructure Requirements 9. Change Control 10. SOPs