Pharmacovigilance Inspection Readiness and CAPA Fundamentals

• Preparing for national and international PV inspections 
• Applying regulatory requirements in daily practice 
• Developing effective CAPAs with strong root cause analysis 
• Fostering a prevention-oriented quality culture

This seminar provides a practical foundation for achieving inspection readiness in pharmacovigilance (PV) and implementing effective Corrective and Preventive Actions (CAPA). Participants will gain a comprehensive understanding of inspection types, key regulatory expectations, and how to prepare documentation, systems, and teams. Core elements include handling realtime inspections, audit strategies, and aligning CAPA processes with international standards such as FDA 21 CFR 820.100, ISO 13485, and ICH Q10. Through real-world examples and actionable tools, attendees will learn how to identify root causes, avoid common CAPA pitfalls, and drive sustainable quality improvements. The seminar empowers PV professionals to enhance compliance, ensure patient safety, and foster a preventive, inspection-ready culture within their organizations.