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.
More articles from Angel Buendia
On October 20, 2022, I had the unique opportunity to attend Evgeniya Makarova‘s virtual talk at Scilife’s Smart Quality Summit. I must admit: I was very excited to listen to her speech. I even bought brand-new white AirPods for the occasion! As a pas...
510K and Premarket Approval are both feasible routes for filing a medical device application in the USA. Similar to other US FDA regulatory frameworks, the applicability of the 510K (also known as Premarket Notification) and Premarket Approval is dec...
Implementing a Quality Management System is key to ensuring consistency in all your processes and, ultimately, guaranteeing your product quality and safety. A well-established QMS will allow you to meet both customer and organizational requirements, ...
Why GAMP 5 Needed a 2nd Edition GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP Computer Systems in regulated industries – including the Life Sciences. Recent technologi...
In GxP-compliant environments, the importance of having a skilled and reliable workforce cannot be overstated. Maintaining employee training and competence records is not a choice but a mandate in the highly regulated Life Sciences industry.
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