Miguel Fagundes is a Qualified Person eligible and experienced in QA/Operations with 15 years leading pharmaceutical manufacturing, quality assurance, and regulatory compliance across global markets. Proven track record in building state-of-the-art facilities, and implementing quality management systems, overseeing GMP operations and quality, leading tech transfer from R&D to commercial scale. Certified Lean Six Sigma Black Belt with deep knowledge of EMA/FDA regulations and a continuous improvement mindset.
As advanced manufacturing technologies reshape pharmaceutical production, the Qualified Person (QPs) must evolve from a traditional document reviewer into a digitally fluent leader capable of navigating complex data ecosystems, real-time analytics, and automated control systems. This article presents a holistic framework for “Certification by Design,” highlighting how QPs can ensure compliant, agile, and science-based batch release in the era of Industry 4.0.
