Marie E. Dorat is a seasoned regulatory and quality compliance professional with over 25 years of experience in the medical technology, biotechnology, and pharmaceutical sectors.
A Certified Lead Auditor for ISO 9001, 13485, 14001, 17025, 27001, 45001, IVDR, and MDSAP, Marie specializes in GCP and cGMP compliance, CAPA remediation, validation processes, and consent decree management. As CEO of M.E. Dorat Consulting, LLC, she provides specialized services in GxP audits, quality management system development, FDA and EU submissions, and international product registrations for in vitro diagnostics, medical devices, pharmaceuticals and biologics.
In partnership with certifying bodies, she facilitates ISO certifications, GxP training programs, and electronic quality management system implementations.
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