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
When the updated European Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostic Regulation (IVDR, 2017/746) were issued in 2017, the European Commission increased the requirements for monitoring the behavior of medical devices in the mark...
It is now well known by the Life Sciences community that the new version of EU GMP Annex 1, which was issued on 22nd August 2022, will come into force on 25 August 2023 (with the exception of chapter 8.123 "Product transfer/loading/unloading areas fo...
Quality Assurance (QA) is an essential process in life sciences organizations, regardless of their size. It involves ensuring that products, services, and processes meet specific standards and regulations, and meet the needs and expectations of custo...
If you have ever sat through an FDA inspection, you know the atmosphere. It is quiet, tense, and strangely similar to watching someone test a structure you built with your own hands. You might feel confident in your SOPs, your training records, and y...
What is Pharma 4.0? Pharma 4.0 is the trademark of an initiative from the International Society for Pharmaceutical engineering (ISPE). Pharma 4.0 refers to the use of Industry 4.0, also called Smart Factory technologies, to improve quality and effici...
The European Medicine Agency’s (EMA’s) 3-year “Work Plan” for the Quality Domain is a strategic roadmap set by the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group (IWG).
It’s that time of year again! The time to start planning your conference calendar for 2026. As always, we’re here to help you navigate what’s ahead in the medical device industry, with plenty of opportunities to get inspired, exchange ideas, and take...
2026 is shaping up to be a decisive year for pharmaceutical and biotech professionals. Regulatory expectations continue to tighten, innovation cycles are accelerating, and cross-functional collaboration is key. Conferences are no longer just about di...
On October 20, 2022, I had the unique opportunity to attend Evgeniya Makarova‘s virtual talk at Scilife’s Smart Quality Summit. I must admit: I was very excited to listen to her speech. I even bought brand-new white AirPods for the occasion! As a pas...
510k vs PMA represents two feasible routes for filing a medical device application in the USA. Similar to other US FDA regulatory frameworks, the applicability of the 510K (also known as Premarket Notification) and Premarket Approval is decided based...
You’ve probably heard all kinds of advice and guidance for how to implement a Quality Management System. Some helpful. Some overwhelming.
Why GAMP 5 needed a 2nd edition GAMP 5 (Good Automated Manufacturing Practice) is a risk-based approach for the implementation, operation, and validation of GxP computer systems in regulated industries – including the life sciences. It’s owned and ma...
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