Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Qvents compilation of regulatory guidelines on Data Integrity : FDA guidance for design, operation, and monitoring of systems and controls based on risk to patient, process, and product, Role of management, ALCOA++, meta data and audit trail, MHRA focus on organisational culture and data criticality based systems, WHO explanation of data governance and arrangements to provide assurance of data quality, Hybrid systems, Data Management and Pharma Quality Systems, PIC-S guidance, EMA and FDA requirements comparison, Data Integrity checklists
