FDA Expert Witness
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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