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Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member.

She has conducted over 200 domestic and international inspections, including cGMP, QSR, drug/API pre-approvals, and GCP/Bioresearch Monitoring. She has also conducted quality system audits, mock inspections, and gap assessments to determine compliance with current Good Manufacturing Practices (cGMPs) for combination products, medical devices, pharmaceuticals, biologics and human tissue.

Expert has an expansive knowledge of pre- and post-market FDA regulations and requirements for medical devices, pharmaceuticals, biologics and combination products. She is highly experienced in effectively interpreting FDA-483/inspectional observations, warning letters, and other agency issued compliance documents.

Expert is fully certified in all areas of pharmaceutical inspectorate training, including regulating pharmaceutical quality and the relationship to FDA’s mission; risk management, advanced quality systems, pharmaceutical science, process analytical technology, current regulatory programs and procedures, technology, and investigational modules. She has conducted numerous presentations at FDA and industry conferences and training sessions.

Expert has spent the last decade consulting independently on the topics of FDA regulations in pharmaceutical, medical device, bioresearch and biotechnology. Examples of her work include:

Conducted gap assessments and mock FDA inspections for multiple medical device manufacturers of dental chair and x-ray equipment as well as surgical sutures/needles. Critical observations were found in the areas of CAPA, Management Controls, and Purchasing Controls. The assessments resulted in detailed observations with recommendations for improved compliance, as well as the development of extensive corrective actions and remediation activities.

Conducted a mock FDA QSR audit of an assembler of cardiac defibrillators. Critical observations were found in the areas of Production Controls and Purchasing Controls, which resulted in significant corrective action and remediation recommendations.

Conducted mock QSIT audits for a combination product manufacturer of an anticoagulant biological mesh and remediation, with critical observations found in the area of Production and Process Controls.