Senior Quality/Regulatory Consultant
Diane has more than 15 years experience with a variety of quality and regulatory positions in the medical device and pharmaceutical industries. She has extensive experience with both domestic and international regulatory filings for medical devices. Diane has prepared both 510k submissions and Technical Files for medical devices and negotiated with FDA, Notified Body and ConMed Corp. in pre-submission and product approval activities. She has led teams responsible for coordination and development associated with pre-submission builds for pharmaceuticals. Diane has also managed successful transitions of various product builds from product development to pilot production and clinical use.
- Reviewed and developed regulatory requirements for QC systems and processes including FDA 483 Inspections & Warning Letters; Management Procedures & Training for Regulatory Inspections; Complaint Handling & CAPA Systems; Documentation Systems; Validation Master Plans; Design/Change Control Requirements; U.S. Labeling & Branding Requirements, EU CE Marking; Process & Software Automation and Validation Controls; Manufacturing Processes & Process Validations; Third-Party Procurement & Supply; Audit Compliance Reports.
- Developed, established, implemented & re-engineered quality systems for sustained cGMP, QSR, GCP, and GLP-FDA compliance for several startup companies.
- Re-engineered and implemented new closed loop CAPA-feeder NCR process for large Medical Device client. Actively participated in the re-engineering and implementing the new FDA & Corp compliant CAPA process.
- Performed external and internal audits to QSRs and cGMPs. Prepared and audited all 510k, IDE and PMA packages prior to filing to FDA. Performed internal audits (including auditing of regulatory documentation, clinical trial data for adequacy and accuracy, investigational product adverse event reporting requirements) to identify if clinical studies were designed, conducted and documented in accordance with applicable SOPs and GCPs.
- Developed and provided input to study protocols for product testing including bioequivalence and GLP trials.
- Participated in setting up Stability Programs for Solutions, Gels, and Drug-coated devices; reviewed protocols and final test reports for submission to US and other government agencies.
- Prepared and assisted with submission amendments and PMA supplements for cardiovascular stent, respiratory, orthopedic implants, and other medical devices.
- Experienced in submission of 510(k), IDE, Original PMA & PMA Supplements (30D notices, Real-time reviews, 180D Supplements).
- Reviewed adverse drug reaction reports and medical device reports. Ensured implementation of necessary corrective actions based on results of inspection, audits and failure analysis. Prepared Waiver Letter, ANADA and NADA packages, as well as the CMC sections for FDA submission.
- Reviewed advertising and promotional materials, as well as product labeling for adherence to FDA and FTC regulations and guidance documents. Reviewed and approved draft labeling for FDA, Canada and EC registration documents, reviewed documents, and acted as liaison to IRB for clinical evaluations of unapproved products.
- Experienced in validation project management, GLP Analytical Laboratory Equipment validation (FTIR, UV-VIS, and HPLC), equipment/systems (packaging line, mixers, fillers, incubators, autoclaves), computer system validation (SAP, JDE, and MAS90), commissioning, startup, qualification (IOP/Q). Also, expertise in process validation of pharmaceutical manufacturing/packaging processes, audits/assessments, preparation of all validation. documentation, and all related regulatory documentation required for FDA approval or certification of facilities.
- Developed cleaning validation protocols, execution and reports for major cleans between products for pharmaceutical manufacturer.
- Consulted on QA/Regulatory product development teams where she performed QA Design Control activities, evaluated suppliers for potential manufacturing sites, partners, acquisitions, and/or business units, documented corrective actions, and surveillance until closure.
- Senior Quality/Regulatory Consultant – BioTeknica, Inc.
- Regulatory and Quality Consulting – Independent
- Manager, Regulatory Affairs/Clinical Development – Ivax Research, Inc.
- Manager, Clinical Quality Assurance – Ivax Research, Inc.
- Associate Director of QA/QS for Medical Devices – GMP Companies, Inc.
- Manager, International Product Registrations/Scientific Specialist – Linvatec
- D.V.M. – Louisiana State University
- M.S., Biology (Concentration in Parasitology) – Loyola University of Chicago
- B.S., Chemistry – State University of New York
- Professional/Candidate MPH in International Health (Epidemiology)