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.
Standard operating procedures (SOPs) describe, well, the standard operating procedures of a company. They provide step-by-step instructions on how to perform the most common tasks at a company. When SOPs are efficient, they decrease miscommunication ...
The FDA is transitioning from Computer System Validation (CSV) to Computer Software Assurance (CSA) for computers and automated data processing systems used as part of medical device production or medical device quality systems. So, what is the diffe...
Quality risk management is a non-negotiable requirement to comply with ISO 13485 and 21 CFR 820. Yet, every year, Life Sciences companies face warnings from regulatory bodies, such as the FDA in the U.S., the EMA in Europe and MHRA in the U.K. Warnin...
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