Topics and Course Content
The Pharmacovigilance Audits & Inspections Training Course will cover topics such as:
- Legal bases for PV audits and inspections
- Preparation for PV Audit and/or Inspection – Headquarter, Affiliate, Business Partners
- Departments and activities that might have an impact on the PV system
- Audits in and outside European Union
- Pharmacovigilance Audit and Inspection Findings
- Preparation and Monitoring of CAPAs
The content of the course is structured to encourage delegates to:
- Work in small groups
- Put into practice the skills learned during the lectures
- Pass a test in the end of the course & test evaluation
- Consult your specific situations with experts on PV auditing in Europe and beyond
- Share experience with PV professionals