Preparing for an FDA & EU Audit

Auditing is a critical function within pharmaceutical manufacturing because it provides management with insight into how effectively the quality system protects product and patient safety. A GMP-licensed manufacturer must always be audit-ready — not just for annual inspections but for surprise audits as well.
This course equips participants with the skills, tools, and strategies required to prepare for FDA and EU audits, handle inspection activities confidently, respond professionally to findings, and maintain long-term inspection readiness throughout the Quality Management System.