Nitrosamine Risk Assessment In Pharma: Fda, Ema & Ich Guide
Published 4/2026
Created by Roche Eduction Services
MP4 | Video: h264, 1920x1080 | Audio: AAC, 44.1 KHz, 2 Ch
Level: Intermediate | Genre: eLearning | Language: English | Duration: 18 Lectures ( 1h 16m ) | Size: 360 MB
Learn nitrosamine impurities, risk assessment, FDA/EMA compliance, ICH M7 & audit-ready GMP documentation
What you'll learn
✓ Understand nitrosamine impurities, their sources, and their impact on drug safety and regulatory compliance
✓ Apply a step-by-step nitrosamine risk assessment aligned with FDA, EMA, and ICH M7 guidelines
✓ Identify and mitigate nitrosamine risks in APIs, manufacturing processes, and pharmaceutical products
✓ Prepare audit-ready...