Category: GMP

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Published By VTI Life Sciences Introduction The pharmaceutical industry is undergoing a significant transformation driven by digitization and artificial intelligence (AI). As regulatory expectations from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) continue to emphasize data integrity, traceability, and compliance, Good Manufacturing Practice (GMP) systems must […]

Created by: Valerie Mulholland, Senior Director / Principle Consultant, GMP Services Ltd & Anne Greene, Director PRST, Technological University, DublinThe Pharmaceutical Regulatory Science Team (PRST), founded in 2005, carries out research into strategies to address the challenges and opportunities of implementing science and risk-based decision making and manufacturing approaches. Since its inception, the PRST has […]

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Andrea Roether, Senior Director of Global Quality, Creation Technologies

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Kelly Menze, Senior Global Supplier Quality Engineer, Creation Technologies; Andrea Roether, Senior Director of Global Quality, Creation Technologies

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Ravi Nabar, Senior Vice President, Quality and Regulatory Compliance, Compliance Group; Steve Silverman, President, The Silverman Group

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