Menu Back to How-to-Prepare-for-a-Safety-Inspection


Every pharmacovigilance department will, at one time or another, undergo a government or health authority inspection. There will more audits by vendors, partners, suppliers, internal auditors, and others. This course teaches participants to prepare for an audit/inspection, from the time they learn about the inspection (or from the time the inspectors arrive at the doorstep) to audit conclusion.
Course Level: Beginner

What you will learn

  • How to prepare for an audit/inspection
  • How to prepare response and corrective action plans
  • Different types of inspections and audits from around the world (European Medicines Agency [EMA], UK Medicine and Healthcare Products Regulatory Agency [MHRA], and US Food and Drug Administration [FDA]

Who should attend?

Professionals and experts who work in:

  • Pharmaceutical safety/pharmacovigilance
  • Regulatory affairs
  • Quality
  • Compliance
  • Information technology
  • Medical information
  • Risk management
  • Legal
  • Pharmacology

Learning objectives

Participants who complete this training should be able to:

  • Define the types of inspections and audits that exist and how they differ around the world
  • Discuss the legal basis for inspections and how inspectors do their job
  • Prepare for an inspection: preparing the roadmap, team, tasks, and documents
  • Assess how to handle the actual inspection
  • Discuss how to prepare the response and CAPA
  • Discuss case studies and mock inspections