Inspection Preparedness and CAPA Planning Across Global Regulatory Environments

• Practical Approaches to PV Inspections, Findings, and CAPA 
• Overview and Oversight of PV Inspections 
• Case Management, Signal Management and Aggregate Reports 
• Dos and Don’ts 
• Corrective and Preventive Actions (CAPA)

This webinar provides a comprehensive overview of pharmacovigilance (PV) inspection preparedness and readiness across major global regulatory jurisdictions. Participants will gain practical insights into regulatory expectations, governance frameworks, quality systems, and operational processes that support a compliant and inspection-ready PV system. The session will examine critical pharmacovigilance activities, including QPPV oversight, Pharmacovigilance System Master File (PSMF) management, Quality Management System (QMS) requirements, case processing and reporting compliance, safety database oversight, signal management, aggregate reporting, risk management planning, labeling governance, and clinical trial safety obligations. It will also address the management of pharmacovigilance agreements, vendor and affiliate oversight, and effective cross-functional collaboration with Regulatory Affairs. In addition, participants will review common inspection findings, compare regulatory approaches across regions, and explore best practices for developing, implementing, and monitoring effective Corrective and Preventive Actions (CAPAs). The webinar is designed to help organizations strengthen compliance, mitigate inspection risks, and maintain sustainable pharmacovigilance inspection readiness throughout the product lifecycle.