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FDA QSR & cGMP (21 CFR 820): How to prepare for a US Audit

This course provides a practical guide to FDA requirements applicable to medical devices, focusing on the Quality System Regulation (QSR) and cGMP.

This course belongs to the “International Markets & Export Compliance” line.

Contact our team if you would like a complete training package covering all related topics, or to request a tailored solution.

Abstract

This course provides a practical guide to FDA requirements applicable to medical devices, focusing on the Quality System Regulation (QSR) and cGMP. Through real-life examples and audit simulations, it helps identify the most common critical issues and effectively prepare for FDA inspections.

Key Points

  • FDA QSR and cGMP requirements

  • US audit preparation

  • Common critical issues

  • Real-life examples and simulations

Structure

4-hour course.

Live streaming or on-site at your company, based on your needs.

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