Nitrosamines & NDSRI's: Evolving Regulatory Landscape in Nitrosamines and NDSRI’s analysis.
Nitrosamine Drug Substance-Related Impurities (NDSRI's) are a class of impurities that can form in drug substances and products. These impurities are of significant concern due to their potential carcinogenicity. Regulatory bodies, including the FDA, have established guidelines and acceptable intake limits to ensure the safety and efficacy of medications.
NDSRI webinar series is a comprehensive three-part webinar series designed to provide valuable insights into the evolving landscape of analytical methods and regulatory requirements. This series will cover critical topics that are essential for professionals in the field.
Key learnings:
- Understanding Nitrosamine / NDSRI and their impact on drug safety.
- Latest regulatory guidelines and requirements.
- Navigating Nitrosamines with Agilent 21 CFR compliant mass Hunter Software.
- A focus on components in chromatographic challenges, with examples of NDSRI methods.
- Case studies and real-world applications.
- Column and consumable selection and how it influences the analysis.
- Best practice for method optimization, development, and automation.
- and more
Presenter: Dr. Kuldeep Sharma (Sales Development Manager - Pharma, Agilent Technologies)
Kuldeep Sharma has over 19 years of experience in area/s of Bioanalytical research, Drug metabolism & pharmacokinetics and Pharma regulatory compliance. He has accomplished PhD in Biotechnology. His professional journey covers over 12 years in Analytical research (associated with R&D’s of Zydus Cadila, Lambda, Pliva and Jubilant Biosys) and last 7 years in analytical instruments sales, marketing & business development. With over 21 research articles published in international Journals, He presents convention of continues learning.
Presenter: Dr. Prasanth Joseph (Application Engineer - LC/MS, Agilent Technologies)
Prasanth is an experienced analytical instrumentation professional with a specialization in small molecule applications. Joining Agilent in 2015 as an Application Engineer for LC-MS/MS, he has 19 years of expertise in the field. Prasanth holds a Ph.D. in Environmental Science from Bharathiar University, India, and a master's degree in Business Administration from the University of Buckingham, UK. His extensive knowledge includes developing analytical methods for quantifying genotoxic impurities, analyzing extractables and leachables in pharma and food packaging, conducting bioavailability and bioequivalence studies, and more. Prasanth's proficiency extends to the analysis of phytochemicals, food residue screening, and environmental sample contaminants.
Presenter: Mr. Ankush Sharma (Regional Marketing Program Manager- APAC (Pharma & Biopharma), Agilent Technologies)
Ankush Sharma is a seasoned professional with over 12 years of extensive experience in sales and marketing across the pharmaceutical and biopharmaceutical sectors. His professional journey commenced with a strong educational foundation, earning a Master's degree in Biotechnology. Building upon this knowledge, he furthered his academic pursuits by obtaining a Master's in Business Administration with a specialization in Sales and Marketing, demonstrating his commitment to blending scientific understanding with strategic business acumen. For the past five years, he has been an integral part of Agilent, serving as the Regional Marketing Program Manager for the India and now Asia-Pacific (APAC) region for Pharma and Biopharma Markets.
