FDA Regulatory Consultant Specializing on Medical Devices

Technical Consultant #1563

FDA inspection and investigation of medical devices, pharmaceutical, biologics and food facilities to enforce the FD&C Act.
Conducted international FDA medical device and pharmaceutical inspections in 18 countries.
Medical device Quality System and pharmaceutical cGMP regulations and principles.
QS regulation inspections of the following types of medical device process technologies: Electronic/electrical, sterile (ETO, dry heat, steam, irradiation), plastic, in-vitro diagnostic, metal CNC machining and a variety of product types.
Pharmaceutical cGMP regulation inspections of technologies and product types for: Sterile, oral solid, oral liquid, topical and active pharmaceutical ingredient products.
Technical report writing.

U.S. Food and Drug Administration, Detroit, MI, Grand Rapids, MI, and Kalamazoo, MI, 1976 - 1988 and 1994 - 2009

Consumer Safety Officer

Conducted routine and compliance inspections and investigations of medical device, pharmaceutical, bioresearch (GLP and GCP), biologics, and food facilities in Michigan and Indiana to enforce the FD&C Act (Federal Food Drug and Cosmetic Act).
Conducted international medical device and pharmaceutical inspections in 18 countries.
Selected as a district medical device specialist in October 2007.

The Upjohn Company, Kalamazoo, MI, Senior GMP, 1998 - 1994

Compliance Specialist

Performed domestic and off-shore GMP audits of pharmaceutical and medical device operations, including all dosage forms, APIs, biologics, clinical supplies and sterile medical devices.
Improve GMP compliance and product quality.
Investigated product quality problems.
Coordinated regulatory agency inspections, including NDA pre-approvals.
Worked with multi-function project teams for facility renovations, equipment upgrades, PAI (Pre Inspection Activities) preparations and consulted on GMP issues.

Credentials

Certified as a level II medical device investigator with FDA.
Certified as a Performance Auditor with FDA.
FDA Outstanding Achievement Award for sustained superior performance in consumer protection, leadership and willingness to share expertise with industry and FDA.
FDA Outstanding Employee Award, Detroit Federal Executive Board.