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
Quality management is the foundation of medical device manufacturing, as it interlinks with every aspect of the process, from design and development to post-market surveillance. Quality management systems (QMS) are deeply entrenched in the industry a...
This is a story of triumph over tragedy. A story shaped by pivotal events that stress the importance of regulatory oversight in the production of pharmaceuticals and other medical products. This is the story of how the Good Manufacturing Practices (G...
Medical devices are a vast category of equipment, treatments, and functional aids, ranging from caries detection software to contact lenses, orthopedic implants, respiratory care, and more. Every person will need a medical device at some point or ano...
Ensuring compliance with 21 CFR Part 11 and EU GMP Annex 11 is crucial for any Life Sciences company using computerized systems in this highly regulated landscape. Both 21 CFR Part 11 and EU GMP Annex 11 act as safeguards for the Quality, integrity, ...
Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading this post to ...
We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.
Developing and bringing a medical device to market is a scary process. Not only do you have to come up with a great idea or design improvement and develop a working prototype, but you must also ensure the device is safe and performs as intended in an...
Quality is paramount in the Life Sciences industry. After all, the safety and efficacy of its products can have a direct impact on patient health.
ISO standards are some of the most recognized global harmonized standards currently at work, along with the standards issued by IEC.
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 ...
Quality professionals in the life sciences industry are dedicated to achieving the highest standards of quality, safety, and efficacy in all products, while also improving manufacturability. Medicines must meet the intended use. To accomplish this, t...
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...
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