FDA Expert Witness | Texas

FDA Expert Witness | Texas

FDA | E-015772

Expert Qualifications

This expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

Bio Snapshot

Location: Texas

BS, Chemical Engineering, University of South Carolina

Certified: Regulatory Affairs Professional

Certified: ASQ Quality Auditor

Certified: RAB Quality Management System Lead Auditor

Founder, ASQ Biomedical DFW Discussion Group

Founding Member, FDA Dallas District/Industry Medical Device Coalition

Member, Regulatory Affairs Professional Society

Member, American Society for Quality - Audit Division & Biomedical Division

Award Winner: FDA Commendable Service (1990,1991,1992)

5+ Publications

Former, Southwest Regional Medical Device Specialist, US Food & Drug Administration

Current, FDA Regulation Consultant in Private Practice

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