- 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.
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.
- Numerous patents and presentations, list available up request.
- Ph.D. Biochemistry, University of Wisconsin
- M.S. Biochemistry, University of Wisconsin
- B.S. Chemistry, Indiana University