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
Regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are undergoing significant changes to meet the challenges and opportunities posed by this technology.
While sometimes deprioritized, regulatory compliance is critical for medical device manufacturers. And among the global regulatory frameworks, the Medical Device Single Audit Program (MDSAP) has gained prominence over the past decade. MDSAP is a comp...
Having the FDA knocking on your door for medical device inspections is scary! But the management of FDA inspections for medical devices is a critical aspect of ensuring compliance with regulatory standards and maintaining the integrity of the medical...
If you’ve been on the lookout for a go-to resource offering valuable tips for technical writing, your search is finally over. We’re here to simplify complexity.
Quality can help organizations drive compliance and growth, as well as reduce costs, by shifting from being an operational compliance issue to a strategic business initiative.
The United States Food and Drug Administration (FDA) is the regulatory body responsible for the safety and efficacy of medical devices in the United States. The 510(k) clearance is their classic premarket clearance for Class II medical devices that m...
We all know that in the European Union, Life Science companies that export to the United States must comply with 21 CFR Part 11. The regulation, overseen by the US Food and Drug Administration (FDA), oversees electronic records and electronic signatu...
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 ...
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