GxP Standards: GMP, GDP, GCP (FDA, EMA, WHO, ICH)

The course covers all aspects of GxP: GMP (FDA 21 CFR Part 210/211, EU GMP, WHO TRS), GDP (EU GDP Guidelines, WHO), GCP (ICH E6, FDA 21 CFR Part 312). Includes validation, audits, inspections, documentation, quality management, risk management (ICH Q9), pharmacovigilance and electronic records (21 CFR Part 11, Annex 11).