Master NDSRIs: Method Development & Validation (Nitrosamines - The LC/MS Edge)
Join "Nitrosamines-The LC/MS Edge" virtual connect series for the second episode, "Master NDSRIs: Method Development & Validation."
Learn all about NDSRIs and their impact on drug safety and compliance. Engage with experts in the Q&A session and gain valuable insights. With increased regulatory scrutiny on nitrosamines, it's crucial to ensure the accuracy and reliability of testing methods. Stay ahead in drug safety and compliance. Register now to secure your spot!
What you'll learn:
Critical process of developing and validating an LC-MS/MS method for NDSRI detection and quantification.
Latest regulatory requirements and guidelines for NDSRI detection and quantification.
Best practices and strategies for method optimization, validation criteria, and quality control procedures.
How to overcome challenges and ensure compliance with global regulations from an experienced industry speaker.
Presenter: Mr. Kailash Bari (Sr. GM Quality, Alkem Laboratories Ltd, Bharuch, Gujarat)
With over 23 years of experience in the pharmaceutical industry and a postgraduate degree from Unibversity of Mumbai, Mr. Bari has worked in public testing laboratories and reputable companies like Lupin, Watson, DRL, Zydus Cadila, and Alkem. He has expertise in Quality Control and Quality Assurance in synthetic API, Fermentation, Oncology, and peptide manufacturing organizations.
Presenter: Preeti Bharatiya (Application Engineer LC-MS/MS, Agilent Technologies)
As an Application Engineer for LC-MS/MS at Agilent India, she specializes in supporting Pharma workflows. With a background as a Pharmacist and an MS in Pharmaceutical Sciences from NIPER, she has significant experience in the pharmaceutical application area of LC-MS/MS. Her expertise lies in drug impurity analysis, specifically in Nitrosamines quantitation using UHPLC-Triple Quadrupole as a platform. She also has experience in the pre-clinical drug development phase, including pharmacokinetic and toxicokinetic studies, drug tissue distribution studies, and rapid-automated sample preparation for biological matrices.
