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 […]
Panelists:Gaurav Walia, VP of CSV/CSA/DI & Digital Governance, Head of Chicago PQE Office & Local Equity Partner, PQE GroupCindy Duhigg, Senior Principal, Global Manufacturing Science & Technology Engineering, AlconRebecca Fuller, Vice President, Regulatory Compliance, QualityHub As quality and compliance expectations continue to evolve across the life science industry, organizations are being called to rethink and […]
AI | Article | Data Integrity | GMP | White Paper
Ronald D. Snee, PhDSnee Associates, LLC In the pharmaceutical world we talk a lot about Data Integrity. The FDA (2016) published A guidance for industry on matters involving data integrity. We hear analysts talking about Data Quality. Legal proceedings often question the “Chain of Custody of the Data.” Metadata is also of concern when assessing […]
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