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
