This on-demand webinar presents a case study of risk assessment implementation and covers analytical methodologies for N-nitrosamines with their challenges and suggested solutions. By watching this presentation you will: 1) Get background information on risk assessment and control of N-nitrosamine contamination in drugs, 2) Understand method development approaches and how to deal with the challenges and 3) Learn to overcome analytical challenges presented by APIs and drug products.
Nitrosamine compounds are classified as probable human carcinogens by the International Agency for Research on Cancer (IARC).
Since 2018 and the detection of nitrosamine impurities in various drug batches, health agencies have required pharmaceutical companies to implement risk assessment about the possible presence of N-nitrosamines in their products.
This involves increasingly stringent regulatory requirements for the analysis of these contaminants.
This on-demand webinar presents a case study of risk assessment implementation and covers analytical methodologies for N-nitrosamines with their challenges and suggested solutions.
By watching this presentation you will:
- Get background information on risk assessment and control of N-nitrosamine contamination in drugs
- Understand method development approaches and how to deal with the challenges
- Learn to overcome analytical challenges presented by APIs and drug products
The presentation is ideal for:
- Laboratory scientists working in pharmaceutical Analytical R&D and involved in method development
- QA/QC managers involved in risk assessment implementation of nitrosamine contamination
- Those interested in the analytical methodology aspects of N-nitrosamine analysis in APIs and drug products
Presenter:
Dr. BM Rao
(VP & Head - CQC, ASAT & EM QA, Dr. Reddy's Laboratories Limited, Hyderabad, India)
Dr. BM Rao has 30+ years of experience in pharmaceutical Analytical R&D, Quality Control & Assurance functions in organizations including Janssen, Novartis, Zydus Cadila, Nicholas Piramal, and Dr. Reddy’s. He has extensive hands-on experience on analytical instruments/techniques related to chromatography, spectroscopy and thermal analysis, and exposure to various regulatory audits includes USFDA, EMA, TGA, Health Canada etc.
