Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices
ID: 732491 Washington, USA
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.
|Year: 1990||Degree: MA||Subject: Business||Institution: Webster University|
|Year: 1983||Degree: BS||Subject: Nursing||Institution: Mount Marty College|
|Year: 1980||Degree: BS||Subject: Education (Minor in Biology)||Institution: University of Nebraska, Lincoln|
|Years: 2006 to Present||Employer: Undisclosed||Title: Senior Consultant||Department:|
Responsibilities:Expert works with clients in the pharmaceutical, medical device, bioresearch, and biotechnology industries to develop quality assurance and regulatory strategies for compliance with FDA regulations. She conducts cGMP audits, mock inspections, supplier audits and due diligence audits of pharmaceutical manufacturers (all dosage forms), Active Pharmaceutical Ingredient (API) manufacturers, sterile drug manufacturers, control laboratories, biopharmaceutical based companies, and medical device manufacturers and assemblers.
|Years: 2003 to 2006||Employer: Food and Drug Administration (FDA)||Title: Drug and Medical Device Investigator / Pharmaceutical Inspectorate||Department: Seattle District Office|
Responsibilities:She was relied upon to conduct the most complex drug and medical device inspections. Expert was the key District resource in developing evidence to support regulatory decisions and actions as related to pharmaceutical and medical device inspections. She provided training to investigators, chemists, and other District staff in the areas of pharmaceutical and medical device GMPs.
|Years: 1999 to 2003||Employer: Food and Drug Administration (FDA)||Title: Supervisory Consumer Safety Officer; Drug Pre-Approval Supervisor||Department: Los Angeles District Office|
Responsibilities:Expert managed the inspectional activity of the drug-approval group, covering 400 drug manufacturers of sterile drugs, tablets, capsules, aerosols, transdermals, active pharmaceutical ingredients, medical gases, and veterinary drugs. She performed technical and investigative work covering Southern California and Arizona.
|Years: 1994 to 1999||Employer: Food and Drug Administration (FDA)||Title: Consumer Safety Officer||Department: Denver District Office|
Responsibilities:As District Drug Specialist, Expert conducted complex inspections (GMPs, Pre-Approval, and APIs) of domestic and foreign drug manufacturers. She recommended new drug approval or regulatory action based on inspectional findings. She conducted joint drug inspections with National Experts, Analysts, Microbiologists and CDER personnel.
|Years: 1990 to 1994||Employer: Food and Drug Administration (FDA)||Title: Consumer Safety Officer||Department: Los Angeles District Office|
Responsibilities:She conducted complex inspections of drug, bioresearch monitoring, and blood bank companies, focusing on GMP and Pre-Approval inspections. She also conducted independent investigations of consumer complaints and tampering, including the review and collection of pertinent records and samples. Expert conducted joint inspections with CDER personnel and also developed evidence for regulatory purposes.
|Awards / Recognition|
|Expert is the recipient of over a dozen Public Health Service (PHS) commendations and Food and Drug Administration (FDA) awards in recognition of superior work and performance, including but not limited to: three (3) PHS Unit Commendation Medals; three (3) PHS Achievement Medals; and a PHS Bicentennial Unit Commendation.|
|Publications and Patents Summary|
|She has five publications/presentations concerning FDA pharmaceutical inspections, drug inspections, and compliance.|
Fields of Expertise
public health, Food and Drug Administration, pharmaceutical manufacturing, pharmaceutical technology, biologic (product), Food and Drug Administration regulation, drug regulation, Good Manufacturing Practice, Current Good Manufacturing Practice, Current Good Manufacturing Practice auditing, medical device manufacturing, Good Clinical Practice, aseptic pharmaceutical process validation, active pharmaceutical ingredient, quality system, process analysis, drug validation, sterility, medical device sterility, human tissue, medical device process validation, process validation, pharmaceutical water treatment system validation, risk management, FDA medical device regulation, biotechnology