Regulatory Affairs and Compliance Auditing


This module reviews the latest European and US regulations for pharmaceutical and medical devices. The quality system standards/regulations/guidelines are reviewed for Europe and the US and the auditing approaches used to demonstrate compliance are explored. 

Learning Outcomes

  1. Evaluate the EU and FDA Quality System requirements for medical devices and pharmaceuticals

  2. Interpret the marketing authorization and regulatory pathways for pharmaceuticals and medical devices in the EU and the US.

  3. Explain the principles, requirements and practices of compliance auditing 

  4. Detail a system for investigation of non-conformances, identification of root cause and corrective / preventive actions.

  5. Participate in an audit, identifying any non-conformances and generation of an audit report

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