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