Christine Zomorodian

Christine Zomorodian

Gish Consulting

A regulatory strategy and compliance evangelist consulting on quality, process and technical solutions for the medical and healthcare industries, Christine lectures at the University of Washington and across the country. She supports businesses in bringing innovative, high-quality, safe and effective products into the marketplace and to thrive and maintain compliance once they get there. Christine’s background extends from a degree in international studies followed by clinical laboratory science and research, followed by a Master’s in Regulatory Affairs. Experience in biologic drugs, supplements, software development and complex medical devices informs her practice in operational, research, development and compliance creating a well-informed perspective, that brings increased value for her clients.

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Specialties: Quality Systems architecture, development and remediation, post-market data and risk analysis for startups and acquisitions, gap analysis, audit and inspection readiness, program & process development, ISO/IEC/ANSI standards and regulation compliance, CAPA & supplier programs, contamination, validation (HF & usability) and verification test design, and guidance interpretation. Working knowledge in FDA QSR & cGMP, EU MDD/MDR/MEDDEV, CMDCAS, IMDRF, ISO 13485:2016/9001/14155/14971/17025, MDDS, GAMP, ICH, Value Stream, Kaizen, IEC 60601-1/62353/62366, DSHEA, HACCP, CLIA, Health IT, applied statistics, and other assorted industry standards.