Apac Kelvin Hooi

Kelvin Hooi is a Senior Principal based in APAC with extensive expertise in international regulatory requirements, particularly in FDA-controlled environments.

His professional experience includes managing multidisciplinary teams across various countries to implement FDA-related projects, with a focus on Combination Products and Medical Devices within the realm of Quality and Compliance.

Kelvin is adept at establishing robust GMPs/QSRs processes, defining procedures, and setting up metrics and dashboards to enhance quality outcomes, with a keen understanding of FDA's strategic importance.

With over two decades of experience in manufacturing operations spanning China, Germany, Finland, Switzerland, Singapore, Malaysia, USA, India, and Indonesia, he has consistently ensured full regulatory compliance while driving improvement initiatives and implementing Lean manufacturing practices, resulting in notable enhancements in quality and operational efficiency.