FDA Regulatory Consultant Specializing on Medical Devices

Technical Consultant #1563


Expertise

  • 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.

Experience

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.

Honors & Publications

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.

Education

  • B.S. Biology; Minor: Chemistry, University of Wisconsin, Platteville, WI
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