Back to Agenda
FDA Warning Letters on Data Integrity
Session Chair(s)
Anu Virkar, MA, MS, PMP
United States
Seating is limited.
Data integrity continues to be a hot topic as seen in the regulatory inspections and resulting FDA warning letters. Case studies / select samples of warning letters on data integrity, computer system validation, electronic records, and audit trail will open up discussions for data integrity, data life cycle, and ALCOA principles.
Learning Objective : Describe the current trends of FDA Warning Letters on Data Integrity, with exposure to case studies; Discuss data integrity, and general requirements on data life cycle and ALCOA principle.
Have an account?