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Speaker Andrea Roether, Senior Director of Global Quality, Creation Technologies
Article | Biopharma | GMP | White Paper
Jason Brown*, Adare Pharma Solutions and Kim Huynh-Ba, Pharmalytik, LLC *Corresponding Author Nitrosamine impurities have emerged as a significant challenge in the pharmaceutical industry due to their carcinogenic potential and unexpected presence in various drug products. Regulatory authorities including the FDA, EMA, and WHO have responded with strict requirements for identification, risk assessment, and control […]
Moderator:Khaled Moussally, Executive Vice President, Corporate Development & Operations, Compliance Group Panelists:Abhishek Bachchan, Associate Director, IT Security, Risk and Quality, GileadMadhavi Ganesan, Director, Life Sciences, KPMGChris Knerr, VP Technology Strategy, MedTech, Veeva Systems Join us for an insightful webcast exploring how artificial intelligence (AI) is revolutionizing manufacturing processes. This session will delve into the practical […]
Article | Biopharma | GMP | White Paper
Karen R. Zimm, Ph.D.Jeremy Banaszewski, M.S., Temple University Abstract This review article discusses the recent developments surrounding FD&C Red No. 3, a synthetic colorant utilized in various dosage forms. The significance of colorants in product identification and the implications of the FDA’s recent regulatory actions are examined. This article also analyzes historical perspectives, scientific evidence […]
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