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Medical Devices FDA Compliance Expert: Pharmaceutical Sterile Packing, Fermentation and Expert Witness

Technical Consultant #1626


Expertise

  • Blood glucose monitoring devices.
  • Validation of analytical methods, validation plans for facilities and utilities.
  • Regulatory compliance for diagnostic medical devices, bulk chemicals, liquid therapeutic dosage forms, solid dosage forms and bulk API chemicals.
  • Sterile product processing of small and larger volume parenterals.
  • Fermentation processes and semi-synthetic antibiotics production.
  • Solid dosage product processing and controls.
  • Documentation and archiving and paperless systems.
  • Compliance with CFR 21, Parts 11, 210, 211, 620 and 810.
  • Training in compliance.
  • Expert witness for product liability cases.

Experience

Independent Consultant, Present

  • Provided expert FDA compliance solutions for a major Fortune 500 drug and device manufacturer (Abbott) who was issued a FDA consent decree.
  • Functioned as a contract interim GenProbe Corporation Director of Validation and New Facility Qualification.
  • Completed validation of in-line processing equipment, validation of sterilization of small volume parenterals and directed the program for new facility qualifications at Ben Venue Laboratories.
  • Completed validation protocols and reviews for several equipment types at a major device manufacturer completing validation of a new production line.

Pharmaceutical Resources, Vice President Quality, 1999 - 2000

  • Managed all QA and QC Functions, documentation, archiving, transition from pre-K2000 to post-K2000 automated systems.

Morton Grove Pharmaceutical, Senior Vice President of Scientific Affairs, 1993 - 1999

  • Managed Quality Control, Research and Development and Regulatory Affairs.
  • Interacted with FDA on all issues and remediation of ANDA submissions, compliance and validation studies.
  • Managed licenses and renewals.
  • Assistant Compliance Officer for Drug Enforcement for controlled substance surveillance.
  • Validation of contract manufacturing.
  • Validation of analytical methods.
  • Managed product stability systems.

Biotrack, Mountain View, CA, Director of Quality Control, 1991 -1992

  • Managed product quality and environmental controls.
  • Devised methods for control of new instrument used with therapeutic analyte clinical management.
  • Managed product stability programs.

Miles Laboratories, Inc., Elkhart, IN, Corporate Vice President - Quality Assurance, 1962 - 1988

  • Research Biochemist - Section Head: Developed and patented Diastix, Keto-Diastix and other clinical laboratory reagents.
  • Completed development for the Miles glucose monitoring Dextrostix reagent and instrument system.
  • Expert witness for product liability cases for Miles Laboratories reagent based diagnostic products and analyzers.
  • Manager Quality Control analytical method, microbiology laboratories, packaging controls, product stability.
  • As Vice President of Quality Assurance, world-wide responsibilities for Miles product quality (77 sites 14 countries).

Honors & Publications


Academic and Professional Affiliations

  • PMA Quality Control Section: Advisory Committee, Chairman Substantiation of Alternative Analytical Methods resulting in current USP methods of material controls for potency, impurities and degradants.
  • Pharmaceutical Manufacturers Association: Manufacturing and Controls Chairman focused on bringing diagnostics and devices to accountability.

Publications

  • Numerous patents and presentations, list available up request.

Education

  • Ph.D. Biochemistry, University of Wisconsin
  • M.S. Biochemistry, University of Wisconsin
  • B.S. Chemistry, Indiana University
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