Pharmaceutical and Medical Devices FDA Consultant - Expert Witness

Expertise

• Over 30 years of experience in FDA regulated industries.
• FDA regulatory affairs, quality assurance, and compliance with expert skills in good manufacturing practices and good clinical practices for both the pharmaceutical and medical device industry.
• Clinical trials for CRO and Phase III trial for a cardiovascular drug.
• Medical device monitoring studies and site qualification for: Carbon dioxide injector (used by interventional radiologists); angiographic studies of the peripheral vasculature; monitoring of the design and use of materials for surgical staplers and autotransfusion devices.
• Due diligence analysis in the support of several new FDA regulated device firm acquisitions.
• Regulatory Expertise: Audits - ISO 13485, cGMP Part 211, Due Diligence, GCP, Quality System Inspection Technique (QSIT), Quality System Regulation (QSR), CAPA , Failure Investigations, FDA- 483 and warning letter responses, hazard analysis, Out-of-Specification Investigations (OOS), quality assurance, quality control, quality management, preventive maintenance, quality systems development and implementation, SOP development, submissions- 510(k), IDE, PMA, sponsor/clinical monitoring, and training.
• Providing expert testimony for manufacturing microbiological in contamination of products.
• Technical Expertise: Document controls, engineering - manufacturing, engineering - process, engineering - project, medical devices-durable, medical devices-sterile, medical devices - IVD, medical devices-implantable, microbiology, pharmaceuticals - API/ Bulk Chemicals, pharmaceuticals - creams and ointments, pharmaceuticals - non-sterile liquids, program management, project management, quality engineering, risk analysis, sterilization-aseptic, sterilization-ETO, sterilization-gamma, technical writing, validation- process, validation-facility, validation- retrospective.
• Expert testimony for manufacturing of microbiological and the contamination of products.

Experience

Undisclosed Company, President, 1986 - Present

• Principle consultant in a firm which services the medical device and pharmaceutical industries.
• Provide full service regulatory affairs, quality assurance and biological control support on a continuing or individual project basis. Regulatory submissions, clinical trial monitoring, cGMP inspections, QA programs, ISO gap analysis, labeling, total quality, sterilization validation, vendor source audits and organizational planning are some examples of continuing areas of expertise.

Projects

• Monitoring several clinical trials for drugs and devices.
• Consent decree resolution for several other drug manufacturers.
• Multiple FDA submissions for several medical device products.
• Vendor, cGMP, and quality system audits of multiple facilities.
• Installing total quality assurance systems for drug and device manufacturers.
• Qualifying an aseptic processing facility for a drug/device product.
• Managing key associates for large subcontract projects for FDA regulated firms that had significant FDA compliance problems.
• GAP analysis FDA compliance QSR, cGMP and 13485-2003 3rd party supplier audits QSR systems development.

Deknatel,Pfizer Hospital Products, Floral Park, NY, Director, Regulatory Affairs - Quality Assurance, 1979 - 1986

• Responsible for division wide quality operations at three plant sites for regulatory affairs, compliance and laboratory services.
• Direct FDA interaction in support of PMA and 510k submissions.
• Responsible for all product sterilization, validation and testing, coordination of all FDA site inspections and instituting cost effective internal and vendor quality programs.
• Completed a PMA for polypropylene suture for the division.

National Catheter Corp., (Mallinckrodt), Regulatory Affairs Associate Manager, 1976 - 1979

• Complete monitoring of FDA activities in medical devices, GMP compliance, labeling review, complaint handling, consulting in sterilization practices and completion of all regulatory submissions (510k's etc.).

Independent Medical Device Consultant, Miami, FL, 1974 - 1976

Dade, American Hospital Supply, Director of Biological Quality Assurance - Regulatory Affairs, 1971 - 1974

• Directed the control sections of microbiology, quality control, immunohematology, coagulation, labeling and returned goods.
• Completed a major restructuring of the RAQA organization and established a new regulatory/licensing function.

Macbick (CR Bard), Fitzwilliam, NH, Manager of Quality Assurance and, Regulatory Affairs, 1970 - 1971

The Gillette Company, Sterilon Medical Division, Manager Sterilization Quality Assurance Laboratory, 1969 - 1971

All Children's Hospital, St. Petersburg, FL, Department Head Clinical Microbiology

Palms of Pasadena Hospital, St. Petersburg, FL, Medical Technologist

Honors & Publications

Academic and Professional Affiliations

• American Society for Quality (ASQ)
• Regulatory Affairs Professionals Society (RAPS)

Credentials

• Wharton School, Management of Quality

Education

• M.A. Microbiology, University of South Florida
• B.S. Bacteriology, University of Florida