戻る 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.