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Overview

This module is part of the DIA Drug Safety eLearning Program. The Safety Audits and Inspections module provides an introduction to audits and inspections as part of pharmacovigilance. The module provides information about audits and inspections, with specific focus on the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) inspections. The module also discusses common inspection findings, how companies should respond to an inspection, and practicalities of inspections and audits.

Featured topics

  • Types and Scope of Audits and Inspections
  • Common Inspection Findings
  • Responding to an Inspection
  • Corrective and Preventive Action Plan

Who should attend?

Professionals working in the area of:

  • Drug safety & pharmacovigilance
  • Clinical research and development
  • Marketing approval
  • Postmarketing activities
  • Regulatory affairs
  • Medical affairs
  • Quality assurance/compliance
  • Anyone who would like to enhance their knowledge and understanding of drug safety

Learning objectives

Upon completion of this course, participants should be able to:

  • Define audits and inspections, different types, and their scope
  • Describe FDA inspections and possible sanctions
  • Describe European Medicines Agency (EMA) and MHRA inspections, the legal basis for European inspections, the new European guideline on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
  • Discuss inspection findings common to both FDA and MHRA, and to each agency individually
  • Describe how a company should respond to an FDA inspection, including the Corrective and Preventive Action Plan (CAPA)
  • Explain the “practicalities” of inspections and audits – what a company needs do

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