Pharmacovigilance Inspection Readiness and CAPA Fundamentals am 02.12.2025

This seminar provides a practical found- ation for achieving inspection readiness in pharmacovigilance (PV) and implementing effective Corrective and Preventive Actions (CAPA). Participants will gain a comprehensive understan- ding of inspection types, key regulatory expectations, and how to prepare documentation, systems, and teams. Core elements include handling real- time inspections, audit strategies, and aligning CAPA processes with inter- national 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 sus- tainable quality improvements. The seminar empowers PV professionals to enhance compliance, ensure patient safety, and foster a preventive, inspec- tion-ready culture within their organi- zations.