Establishing a Risk based Pharmacovigilance audit program in line with current Regulatory requirements and covering audit types and tools that can be used.

An insight into preparing and managing Pharmacovigilance Inspections and discussing a selection of  Inspection findings to understand the root causes and how these could have been mitigated

Area Covered In The Webinar

  • Background and Regulations for Pharmacovigilance Auditing
  • Designing a QA Pharmacovigilance audit programme
  • Risk Management in design of QA audit programmes 
  • Types of Pharmacovigilance audits
  • Preparing for and Hosting Pharmacovigilance Inspections
  • Inspection Findings

Why should you attend?

  • QA Audit staff at all levels
  • PV Operations
  • PV Responsible Persons

Who Will Benefit

  • QA Auditors
  • QA Management
  • PV Operations


On Demand

Michael Ramcharan (Reumat Consulting) has 30 years of experience in Quality Assurance having worked with multinational Pharmaceutical and Clinical Research Organisations (CRO) mainly in the GCP and G Know More

Michael Ramcharan