Argen Corporation
Shilpi Sinha is an experienced professional in quality and regulatory affairs, currently serving as Head of Quality & Regulatory Affairs at Argen Corporation since May 2023. Prior to this, Shilpi held multiple leadership positions at Inova Diagnostics from May 2013 to May 2023, including Director Quality Assurance. Other notable roles include Quality & Regulatory Affairs Manager at HemoCue Inc. (Quest Diagnostics) and Quality Systems Manager at Focus Diagnostics (Quest Diagnostics). Shilpi's expertise encompasses validation systems, CAPA systems, audits, and risk management systems. Shilpi's educational background includes a Master's degree in Microbiology from the University of Mumbai, Certification as a Medical Device Auditor from ASQ, and Regulatory Affairs Certification from the Regulatory Affairs Professional Society (RAPS).