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
✓ 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 documentation and demonstrate compliance with GMP and global regulatory expectations
Requirements
● No prior experience in nitrosamine risk assessment is required-this course is designed for beginners and professionals new to the topic
● Basic understanding of pharmaceuticals, chemistry, or GMP concepts is helpful but not essential
● Suitable for QA, QC, regulatory, and manufacturing professionals or anyone working in GxP environments
● A willingness to learn regulatory expectations and apply practical risk assessment approaches
Description
Master Nitrosamine Risk Assessment & Become Audit-Ready in Pharma
Nitrosamine impurities are one of the most critical regulatory challenges in the pharmaceutical industry today. Global authorities such as the U.S. Food and Drug Administration and European Medicines Agency have issued strict guidance requiring pharmaceutical companies to assess and control nitrosamine risks in human drugs.
This course provides a practical, step-by-step guide to nitrosamine risk assessment, helping you understand exactly what regulators expect-and how to apply it in real-world pharmaceutical environments.
You will learn how to identify nitrosamine risks across APIs, manufacturing processes, and supply chains, and how to apply a risk-based approach aligned with ICH M7 and global GMP requirements.
What You'll Learn
• Fundamentals of nitrosamine impurities and carcinogenic risk
• How to perform nitrosamine risk assessments step-by-step
• Understanding FDA, EMA, and global regulatory expectations
• Applying ICH M7 principles for impurity control
• Identifying sources of nitrosamine formation in drug products
• Implementing risk mitigation and control strategies
• Basics of analytical testing and detection methods
Why This Course Matters
Regulators continue to increase focus on nitrosamine compliance, and many FDA warning letters are linked to inadequate impurity control and risk assessments.
By completing this course, you will
• Gain job-ready knowledge for QA, QC, and regulatory roles
• Improve your ability to pass audits and inspections
• Understand how to reduce compliance risk and product recalls
• Build a highly valuable skillset in pharmaceutical quality systems
Who this course is for
■ QA, QC, and regulatory affairs professionals working in pharmaceutical or GMP-regulated environments
■ Scientists and analysts involved in API development, formulation, or impurity risk assessment
■ Pharmaceutical manufacturing, validation, and compliance professionals preparing for audits and inspections
■ Graduates and early-career professionals looking to build job-ready skills in pharma compliance and regulatory requirements
Nitrosamine Risk Assessment In Pharma: Fda, Ema & Ich Guide
