Safety Audits and Inspections

The Safety Audits and Inspections eLearning module provides an introduction to audits and inspections as part of pharmacovigilance. 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. Common inspection findings, how companies should respond to an inspection, and best practices for managing safety audits and inspections are also covered in this module.

The module takes an average of 3.75 hours to complete.

This eLearning module can be purchased individually or as part of the Drug Safety eLearning Program (6 modules) or Drug Safety eLearning Bundle (7 modules).

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

-Previous Participant

• 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

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

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

• Identify inspections, possible sanctions, and how a company should respond to an FDA inspection, including the Corrective and Prevention Action (or CAPA) Plan
• Differentiate European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) inspections, the legal basis for European inspections, the new European guidelines on pharmacovigilance inspections, the MHRA’s risk-based approach, and possible sanctions
• Recognize Health Canada safety inspections and after-inspection activities
• List inspection findings common to both FDA and MHRA, and to each agency individually
• Determine best practices for the company’s management of audits and inspections