Senior Clinical/Quality Auditor & Former FDA Investigator

Former FDA Investigator with over 18 years of experience in auditing and compliance, specializing in GCP, GLP, GMP, GVP, and ICH standards. Expert in clinical trial oversight, quality improvement, protocol design, and inspection readiness for global clinical and manufacturing operations. Skilled in developing corrective and preventive action (CAPA) plans, conducting mock inspections, and providing regulatory compliance training for clinical research sites, CROs, sponsors, and compounding pharmacies.

Key Areas of Expertise

  • Clinical Trial Oversight and Compliance Audits
  • GCP, GMP, GLP, and ICH Compliance
  • Mock Inspections and FDA Inspection Readiness
  • CAPA Plan Development and Implementation
  • Vendor Qualification and Monitoring

Professional Experience

Industry Consultant
Various Locations | Dec 2008-Present

  • Conducted routine, directed (for-cause), qualification, re-qualification, and inspection readiness audits of clinical research sites, CROs, sponsors, vendors, and compounding pharmacies to assess compliance with GCP, GLP, ICH, and applicable federal regulations.
  • Developed audit plans and objectives to ensure effective monitoring, clinical data management, and regulatory document accuracy, including reviewing Trial Master Files (TMFs) for essential documents like FDA 1572s, informed consents, and financial disclosures.
  • Delivered training on FDA regulations, inspection readiness, and GCP to clinical and pharmacy personnel and prepared comprehensive audit reports and CAPA plans.
  • Worked as lead consultant for a Middle Eastern pharmaceutical client during their first FDA inspection, ensuring minimal findings and developing a quality and risk management plan for future clinical trials.

Investigator/Consumer Safety Officer – U.S. Food and Drug Administration
New York, NY | 2003-2008

  • Inspected clinical research facilities, blood banks, and tissue banks, ensuring compliance with federal regulations regarding human subject protection, informed consent, and IRBs.
  • Conducted domestic and international inspections, prepared regulatory enforcement recommendations, and trained FDA employees on regulatory guidelines, including bioresearch monitoring and the FD&C Act.
  • Achieved Level I and II Investigator certifications and served as a lead investigator on international inspections.

Clinical Research Associate – Louisiana Best Clinical Research Organization, Inc.
Louisiana | 2001-2003

  • Managed clinical trial oversight for multiple U.S. sites, ensuring protocol adherence, GCP compliance, and data accuracy in clinical monitoring visits.
  • Maintained and audited central files for clinical studies to support compliance with GCP and sponsor SOPs.

Education
Doctor of Health Science
Nova Southeastern University

Master of Education in Health Promotion
University of New Orleans

Bachelor of Science in Biological Science
University of New Orleans

Certifications

  • Registered Quality Assurance Professional – Good Clinical Practice (RQAP-GCP)
  • Certified Clinical Research Professional (CCRP)
  • Master Certified Health Education Specialist (MCHES)

Training and Auditing Experience

  • Provided FDA inspection training on bloodborne pathogens, aseptic sampling, risk-based quality management, and CAPA plan preparation.
  • Conducted audits for clinical trials across all phases (I-IV), as well as for blood banks, tissue banks, and IRBs, ensuring compliance with regulatory standards for GMP, GCP, GLP, and donor safety.
  • Delivered specialized training on FDA inspection readiness, mock FDA inspections, regulatory authority inspection hosting, and common inspection findings for investigator sites.

Awards and Recognition

  • Recognized as a lead investigator in the International Inspection Cadre for multiple international FDA inspections.

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