Independent Quality Systems Associates, Inc.
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Strong individual contributor with over 30 years of multi-disciplinary experience in project management within the innovative and regulated high-technology medical products sector. Demonstrated capabilities in PRODUCT ASSURANCE and REGULATORY COMPLIANCE with the added dimensions of PRODUCT INNOVATION and PROCESS INNOVATION to provide sustainable competitive advantage for clients.
Initiated and validated design safety review for pilot drug substance manufacturing system on behalf of Japanese customer. Involved identification and use of relevant NFPA standards.
Designed, created and implemented product and process documentation systems for quality purposes and for FDA compliance at 10 different companies. Involved use and interpretation of FDA's Good Manufacturing Practices, Quality Systems regulation, and ISO-9000 Quality System Standard.
Redesign activities, including equipment selection and validation, for dialysis concentrate mixing, filtration, and filling lines to prevent microbial problems.
Co-authored original work for HIMA Standard on sterilizing filters.
Collaborated on solving manufacturing and testing problems for a $10MM cartridge filter product using process flow charting and statistical techniques to identify significant variables.
Invented special modification of filters for antibiotic sterility testing which dominated the current $3MM market.
Redesigned and modified an image analyzer product to measure Kirby-Bauer antibiotic inhibition zones for hospital use. (Kirby-Bauer is a de-facto standard)
Led project to remove leukocytes from human packed red cells and platelet rich plasma using affinity ligands on hollow fiber modules. Designed and built associated apparatus for experiments.
Investigated and subsequently modified evaporative film manufacturing process to allow production of wider films and to reduce variability of the resulting structure.
Designed, modified designs, and validated systems for cleaning and disinfecting hoses and containers to meet FDA and AAMI requirements.
Developed hardware and software for portable filtration data acquisition device. Utilized resulting data to optimize process filtration systems.
Established internal audit systems, complete with specific checklists, to review Product(FDA), Workplace(OSHA), and Environmental(EPA) compliance. Trained personnel to carry out comprehensive audits on a periodic basis. Prepared Safety Manuals and Contingency Plans to meet Massachusetts Standards.
Created and filed IND (Investigational New Drug application) for phase I trials of a periodontal disease product using New Molecular Entity. Created and submitted Drug/Device Master Files for chiral drug substance, for bioseparation hollow fiber devices, and for sterilizing grade filter cartridges.
Directed successful efforts to obtain a biologicals product license and establishment license (PLA and ELA) for a unique LAL endotoxin test, meeting FDA Biological Standards requirements.
Preparation of FDA accepted Pre-Market Notifications (510-K) for dialyzer reprocessing units, orthopedic devices, filtration devices, and blood processing devices.
GMP certification audits pursuant to consent decrees for 3 different companies.
1991-present Principal, INQC Consulting, Acton, MA
Management consulting services in Improvement, New processes, Quality
systems, and Compliance systems for technology based companies.
Clients include Remington Products, Garland Manufacturing, National Medical
Care, Filtron Technologies, St. Jude Medical/CAD, Bard, Hemasure,
Infusaid/Strato Medical, Olympic Systems, Tomlin Associates, SoftwareCPR, and
STAT-A-MATRIX.
1996-1999 Principal, EXPERTech Associates, Inc., Concord,
MA
Worldwide management consulting leader for the medical device
industry
1987-1991 Sepracor Inc., Marlborough, MA
Emerging leader in bio-separations products and bioreactor
processes.
Director, Quality Assurance and Regulatory Affairs
Senior Consultant
1965-1987 Millipore Corporation, Bedford, MA
Multinational leader in critical separations technologies
Corporate Planning Coordinator
Director of Corporate Regulatory Affairs
Senior Quality Engineer
Senior Development Engineer
Development Engineer / πMC Systems Manager
Research Engineer
Massachusetts Institute of Technology, Cambridge, MA;
Bachelor of Science in Chemical Engineering, 1965
Mgmt of Personal Computing-Summer Session; 1983
Northeastern University, Boston, MA;
Professional Achievement Courses - Biomedical Engineering, Project Mgmt;
Certificate, 1968
ASQ American Society for Quality, senior member
International Society of Pharmaceutical Engineers, past member
Massachusetts Quality Award, Trained Examiner-1993
Massachusetts Dep't of Environmental Protection, Registered Toxic Use Reduction Planner
PDA Parenteral Drug Association, member
RAB Lead Auditor Training (ISO-9000), RAB Quality Systems Auditor 1996