Nitrosamines Landscape in Tandem with Analytical Technologies: Is Your Lab Nitrosamine Ready?
A 3-part webinar series to help you stay ahead in nitrosamines & NDSRI analysis, from regulatory clarity to method mastery and compliance confidence.
Session 1: Nitrosamines Landscape in Tandem with Analytical Technologies: Is Your Lab Nitrosamine Ready?
Nitrosamines and NDSRIs continue to challenge the pharmaceutical industry with evolving regulations and analytical complexities. This session focuses on understanding the distinctions between nitrosamines and NDSRI's and aligning your lab with the latest regulatory expectations and technology advancements.
Get expert insights into risk assessment, mitigation strategies, and the analytical technologies critical to staying compliant and efficient. The session will feature an exclusive panel discussion with Dr. Saji Thomas, Associate Vice President, Analytical Research & Development, Sun Pharma, who will share practical, real-world insights from the frontlines of nitrosamine testing and regulatory preparedness.
Key Takeaways:
- Understanding the difference between Nitrosamines and NDSRI's
- Regulatory scenarios: API, Formulations, and NDSRI's
- Key updates in global guidance and risk assessment
- Mitigation strategies for NDSRI's
- Industry discussion: evolving testing landscape, workflow challenges, and future directions
- Live Q&A with Agilent and industry experts
Presenter: Dr. Saji Thomas (Associate Vice President, Analytical Development, Sun Pharmaceutical Industries Limited)
Dr. Saji Thomas earned his Ph.D. in chemistry from Kumaun University, Nainital, Uttarakhand. With 32 years of diverse experience in the pharmaceutical industry, he has developed cost-competitive, IP, EHS, and regulatory-compliant technologies for generic APIs, intermediates, radiopharmaceuticals, onco APIs, life science ingredients, animal nutrition products, fine chemicals, CRAMS/CDMO, and drug discovery functions.
He is skilled in chemical analysis, chromatography, solid-state characterization, spectroscopy, impurity profiling, impurity isolation, and structural elucidation using techniques such as LC-MS/MS, HRMS, IR, NMR, and EA. Also excels in developing and validating highly sensitive MS methods for nitrosamines, NDSRIs, and GTIs.
He has extensive experience in pharmaceutical quality management systems (QMS), creating state-of-the-art manufacturing and QA systems, conducting OOT and OOS investigations, identifying root causes, implementing CAPA, and engaging in FDA remediation activities. He is a co-inventor of 25 process patents and has published 14 research papers in international journals.
Currently, Dr. Thomas serves as the Associate Vice President of Analytical Development at Sun Pharmaceutical Industries Limited in Gurugram. His previous roles include positions at Jubilant Pharmova Limited, Indoco Remedies, Jubilant Life Sciences Limited, Solaris Chemtech, and Alta Laboratories Limited.
Presenter: Dr. Kuldeep Sharma (Sales Development Manager - Pharma, Agilent Technologies)
Kuldeep Sharma has over 19 years of experience in the areas of bioanalytical research, drug metabolism & pharmacokinetics, and pharma regulatory compliance. He has accomplished a PhD in biotechnology. His professional journey covers over 12 years in analytical research (associated with R&D at Zydus Cadila, Lambda, Pliva, and Jubilant Biosys) and the last 7 years in analytical instrument sales, marketing, and business development. With over 21 research articles published in international journals, he presents the convention of continuous learning.
