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How to Prepare for a Safety Inspection


This On Demand Training will take approximately 6 hours to complete.

Every pharmacovigilance department will, at one time or another, undergo a governmental or health authority inspection as well as audits by vendors, partners, suppliers, internal auditors, and others.  DIA is pleased to present this introductory online course that will teach you how to prepare for an audit/inspection from the time of the receipt of the announcement (or of the arrival of the inspectors at your doorstep) to conclusion of the audit.

Course Level: Beginner

Part 1:
Module 1 - The Basics

  • Audits vs. Inspections
  • Scope
  • Preparartions

Module 2 -  FDA Inspections

Part 2:
Module 3 - MHRA/EMA/EU Inspections

  • Qualified person fro PV
  • Preparation
  • The Good PV Practices Inspection Module
  • Types of findings
  • Pharmacovigilance System Master File

Module 4 - Common Inspection Findings

Module 5 - Responding to the Findings and Preparing the Corrective and Preventive Actions (CAPA)

  • The response
  • CAPA

Part 3:
Module 6 - What You Really Have to Do

  • General considerations
  • Roles and responsibilities - preparation for inspections
  • Preparation for future inspections

Module 7 - Behavior, Advice, and Comments

  • Demonstration of different behaviors and interviewee response types
  • The Park Doctrine

Module 8 - Case Studies


Featured topics

  • How to prepare for an audit/inspection
  • How to prepare a response and corrective action plans
  • Different types of inspections and audits from around the world (EMA, UK MHRA and US FDA)
  • Review case studies

Who should attend?

Professionals who work in:

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

Learning objectives

At the conclusion of this activity, participants 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

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