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How to Prepare for a Safety Inspection

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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

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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