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

Technical Consultant #1626

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).

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