Nitrosamines Impurities Management

  • Instructor : G. Sundar
  • Level : Intermediate
  • Study time : 87 minutes
  • Course ID: TF3534
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ABOUT THE COURSE

Concerned about nitrosamines in your products?
Unsure how to comply with FDA's NDSRI guidelines?
Need better strategies for risk assessments and supplier controls?


This course offers end-to-end guidance to meet global nitrosamine compliance from chemistry to audit-ready systems.


WHAT WILL YOU GAIN
  • Clear understanding of FDA & global NDSRI regulations
  • Practical tools to perform risk assessments and testing
  • Controls to prevent nitrosamine formation and contamination


WHY TAKE THIS COURSE
  • Stay ahead of regulatory audits and updates
  • Strengthen your quality and compliance frameworks
  • Protect patient safety while reducing recall risks


KEY AREAS COVERED
  • Nitrosamine chemistry and risk formation triggers
  • FDA NDSRI and global regulatory guidance
  • Analytical testing: LC-MS/MS, GC-MS interpretation
  • Manufacturing and cleaning controls
  • Supplier oversight and material compliance
  • Deviation investigations and continual improvement

Quality training, expert insights, and answers that matter. Know your Expert

G SUNDAR

G. Sundar is a pharma quality veteran with over 35 years of hands-on experience in QA/QC, regulatory compliance, and training across the globe. He has conducted 200+ GMP/GLP audits and over 1000 training sessions on regulatory expectations. As Director of PharmQA Compliance, his mission is to empower organizations with quality systems that meet FDA, EMEA, TGA, and WHO standards.

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