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Clinical trial rules get a modern makeover
The FDA has adopted the updated ICH E6 (R3) Good Clinical Practice guidelines, marking the biggest overhaul in decades. The new framework emphasizes risk-based, quality-by-design approaches, stronger ...
Regulators around the world require compliance in Good Practice (GxP) regulations. To learn more about how GxP impacts bioprocessors, GEN talked with Akshay Kapadia, CEO at Conexus Solutions. GEN: How ...
Everyday analysts face situations of decision making instances for handling OOS/ Lab-error (LE). As we all know, quality is a continuous process and no process is ...
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