Ms. Marie Dorat, is a hands on Regulatory/Quality Professional with 23 years experience in the Medical Device, Biopharmaceutical/Pharmaceutical industries in various senior positions.  She has a high level of expertise in the regulatory/quality arenas, with an astute knowledge of GCP, cGMP QMS Development, validation, CAPA, NCMR, Change Control, and Training. Ms. Dorat is also a certified Lead Auditor for ISO/IVDR/MDSAP and has published articles for compliance magazines related to Clinical Site Inspections FDA vs. EU; Developing a compliant Quality System to name two.
She has facilitated e-QMS enterprise development, software validations, worked in a Consent Decree environment and supported remediation projects.