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Safety Audits and Inspections


Overview

This module provides information about audits and inspections, with specific focus on the US Food and Drug Administration (FDA), European Medicines Agency (EMA), the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), and Health Canada inspections. The module also discusses common inspection findings, how companies should respond to an inspection, and best practices for managing safety audits and inspections.


“This course provided a systematic view on Health Authority inspections which highlights FDA, EMA/MHRA inspections and how a company manages inspections!”

-Previous Participant

Featured topics

  • Introduction to Safety Audits and Inspections
  • FDA Inspections
  • EMA and MHRA Inspections
  • Health Canada Inspections
  • Inspection Findings
  • Responding to an Inspection
  • Managing Audits and Inspections: Best Practices for Companies

Who should attend?

This module is designed for professionals involved in:

  • Drug safety and pharmacovigilance
  • Clinical research
  • Biostistics
  • Bioinfomatics
  • Regulatory affairs
  • Quality assurance
  • Compliance
  • Medical affairs
  • Marketing
  • Health and economic outcomes research

Learning objectives

Upon completion of this module, learners should be able to:

  • Define audits and inspections, different types, and the 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
  • Describe the Health Canada safety inspections
  • 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 (or CAPA) Plan
  • Explain best practices for the company's management of audits and inspections

This module takes an average of 3.75 hours to complete.

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