Webinar Date/Time: Thu, Nov 7, 2024 9:00 AM PST (12:00 PM EST)
Learn how to navigate the regulatory landscape utilizing current method development technologies for impurity control in late-phase API manufacturing.
Register Free: https://www.chromatographyonline.com/lcgc_w/control-strategies
Event Overview:
This webinar will cover the method development strategies for control of nitrosamines in drug substances and drug products. There will be a focus on platform method development across liquid chromatography-tandem mass spectrometry (LC-MS-MS), high-resolution LC-MS, and gas chromatography-mass spectrometry (GC-MS), and application of these methods to challenging drug substances and drug products. The webinar will include a review of method development and validation case studies for nitrosamines of concerns, as well as strategies for drug-derived nitrosamines to ensure you bring your drugs into compliance ahead of the August 2025 deadline.
Key Learning Objectives
Who Should Attend
Speaker:
Shankar Sankaran
Director, Analytical
SK pharmteco
Shankar Sankaran is director of analytical at SK pharmteco, where he oversees method development, validation, release testing, stability studies, and reference standard management for both CDMO operations and contract analytical services. With over 16 years at the organization, Shankar previously worked as a laboratory chemist, and has taken on increasing responsibilities in quality control and method development to support API programs from early to late phases and into commercial stages.
Register Free: https://www.chromatographyonline.com/lcgc_w/control-strategies
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