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
Every Quality Assurance (QA) professional knows that a Quality Management System (QMS) is the foundation of product safety and effectiveness in the pharmaceutical industry.
In the pharmaceutical industry, ensuring the safety and quality of medicines is a big responsibility. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) are the two most influential regulatory agencies overseeing drug...
In the fast-paced and highly regulated life sciences sector, maintaining an effective Quality Management System (QMS) is critical to ensuring product quality, compliance, and continuous improvement.
Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...
In the pharmaceutical industry, maintaining patient safety and product quality is not just a regulatory obligation, it’s an ethical imperative. Any oversight can lead to severe consequences, from product recalls to harm to patients, tarnishing reputa...
Pharmaceuticals are one of the most vital industries keeping the world running. Whether you are involved in the industry or not, the quality control and reliability of top drug companies affect everyone at some point.
When we observe the industry advancements, we see that software validation has become an indispensable yet challenging process. As regulations grow more stringent and technologies advance, the demand for smooth validation strategies is at an all-time...
The pharmaceutical industry is highly regulated to ensure the safety, efficacy, and quality of drug products. As part of the FDA’s current good manufacturing practice (cGMP) regulations, 21 CFR Part 211 outlines stringent guidelines for drug manufact...
There’s a common misconception in life sciences that quality “costs” money — that any investment in quality such as an eQMS is just another financial burden. But that couldn’t be further from the truth.
The commercialization of medical devices and drugs depends on a single aspect – patient safety. Patients must know that the device or drug does what it is supposed to do and won’t unintentionally harm them. Enter, quality management. Quality manageme...
A week of intensive United States Food and Drug Administration (FDA) inspection has just concluded for your team, and while there’s a cautious sense of relief, there’s still that persistent concern.
Regulatory submission can bring both horror and delight to the office: it just depends on which stage you are at. Paperwork can be grueling yet equally rewarding when accepted. In the life sciences industry, regulatory paperwork is what gets your foo...
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