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Last Updated: October 3, 2026
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Ever wonder if materials in your container or manufacturing process could be contaminating your In this webinar Kevin Breesch of Nelson Labs will speak about the challenges of toxicological- This presentation provided current expectations for setting acceptable intake (AI) limits for nitrosamine impurities and discuss ... FDA discusses common review issues encountered in ANDA applications on Presented by Kim Li, PhD, DABT, MPH, Amgen Inc. and Erica J. Tullo, Technology Manager, E&L - Analytical Labs, West ... Presented by Dhaval Tapiawala, Principal Scientist at Pfizer and Satish Kumar Mohanvelu, Life Sciences Management ... What's changing with the new FDA guidance on This session offered a case study in which the objective was to analyze and categorize the ten most common deficiencies in the ... The ICH M13A guideline provides a framework for classifying
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