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
Any medical device manufacturer developing new products comes across design verification and validation. They are essential stages during the design control of a new medical device. Design controls are a series of steps and processes during the devel...
The pharmaceutical industry has a responsibility to prioritize sustainability, but unfortunately, it has not always done so in the past. At present, sustainability is often viewed as a trendy buzzword, used by companies to improve their public image ...
With the European Medical Device Regulation (EU MDR, 2017/745), the Unique Device Identifier (UDI) became mandatory for medical device manufacturers in the European Union. The MDR aligned the EU with the US market, where the UDI system had already be...
The US FDA (Food and Drug Administration) is known for many things. However, adaptability and the willingness to harmonize with other regulatory agencies worldwide might not be one of them. Nevertheless, in 2018 the FDA began work to reconcile the US...
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...
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...
In June 2022, the European Medicines Agency (EMA) published its first review of the 3-year work plan for the Quality domain (covering January 2021 to December 2023), highlighting interesting strategies and goals applicable to the Life Sciences indust...
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 and Premarket Approval are both 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 dec...
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. Recent technologi...
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