Angel Buendia
Knowledge Manager, Scilife
With 20+ years of experience shaping quality within pharmaceuticals, Ángel bridges QC & QA expertise in life sciences. His passion for continuous learning, combined with his role as a Smart Quality advocate, drives his dedication to instilling a quality culture, guiding teams with collaborative leadership, and fostering excellence as a cornerstone. He navigates complex regulations, and is driven by upholding high standards and fueling innovation.
Quick answer Draft Annex 22 is the EU's proposed GMP guidance for data-trained AI and machine learning (AI/ML) models used in critical pharmaceutical manufacturing applications. It introduces AI-specific expectations for governance, validation, risk ...
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