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
Thanks to the growing use of AI in drug development, pharmaceutical companies can now sift through all that data to spot patterns, predict failures, and make better decisions faster. From finding promising drug candidates to optimizing clinical trial...
The pharmaceutical industry is under more pressure than ever. Regulatory demands are tighter, production timelines are shorter, and data is more complex. Add global teams and supply chain volatility, and you've got zero room for error.
When working with medical device companies, one thing becomes very clear: the difference between a team that’s audit-ready and one that’s constantly chasing documentation often comes down to a single factor—training. If quality and compliance trainin...
From Lab bench to market: Navigating biotech and pharma Ever wondered what really sets biotech apart from pharma? They're often lumped together, but these two powerhouses of human health take radically different routes to get from concept to cure. Fr...
In the life sciences, compliance is everything, and two of the most critical regulations are Good Manufacturing Practices (GMP) and Good Distribution Practice (GDP).
We all know that pharma companies are duty-bound to control the quality of the drugs they produce—it's paramount for protecting patient safety. One critical part of how they do this is by employing a Corrective and Preventive Action (CAPA) system.
Navigating the EU's pharmaceutical regulations can be a real head-scratcher. But there is one set of guidelines that you absolutely need to know if you are involved in manufacturing medicines in Europe. It is called EudraLex.
As quality professionals, we know that a vital part of keeping patients safe is making sure that drug products are manufactured consistently and that the end products are of high quality. This is pretty much taken for granted by the public today, but...
As one of the most regulated industries on the planet, the challenges in the pharma industry are countless, especially when it comes to managing a pharmaceutical Quality Management System.
Let's be honest, quality management in life sciences can be a real headache. The amount of paperwork, the complexity of the regulations, and the constant pressure of audits is tremendous. It's enough to make anyone's head spin.
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...
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