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
Introduction Despite its crucial role in life sciences, college curricula often overlook technical writing. However, life sciences professionals are expected to possess this skill and demonstrate it at a level that frequently exceeds their capabiliti...
How to get your management team to say “Yes” to an eQMS As a quality professional, you know the value of an eQMS. You’re aware of the drawbacks of manual or paper-based systems and how an eQMS can enhance speed, safety, and efficiency in your organiz...
In the pharmaceutical and medical device industry, manufacturers must make sure medicines and healthcare products are made correctly, stored safely, and delivered to the people who need them. Supply chain management is the planning and organizing tha...
Regardless of your position, whether you are a CEO, or a C-suite executive in the life sciences industry, here at Scilife we understand - every second counts, every dollar counts. Accelerating time-to-market is essential to be competitive.
You’ve finally received your 510(k) clearance and feel ready to start commercialization in the US market. But how do you go about importing your medical devices into the US? Importation is the final hurdle in an often year-long process to obtain regu...
Information runs the world, and in healthcare, every bit of data is important. Every day, hundreds of sets of data are produced as people go about their jobs manufacturing medical products. Every day, almost all of this data is recorded in some way.
A narrow focus on regulatory compliance can hinder organizations from fully embracing and benefiting from quality and operational excellence.
Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
It is almost impossible to work in the medical device space without hearing the term ISO 13485. But what is it? And how can you avoid mistakes during scoping and implementation and ensure the continued availability of your products on the market? Tha...
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Navigating the complexities of FDA inspections is crucial for QA professionals in the pharmaceutical and medical device industries. The stakes are high, with regulatory compliance directly impacting your organization's ability to operate smoothly, av...
The Internet of Medical Things (IoMT) is revolutionizing the MedTech industry by integrating medical devices, wearables, and health applications through Internet connectivity. This transformation enables continuous health monitoring, real-time data e...
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