Find an Expert
ISO 9001-2000/TS 16949 audits, documentation, training, assistance for certification, APQP, SPC
Expert is an ISO 9000 Lead auditor. He has been implementing developed by ISO like ISO 9000, ISO 13485, and ISO 17025 for many years. He has assisted several companies from various industries to become certified from scratch. He has…
Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material…
Personal Injury, Industrial/Construction Safety, Compliance, Auditing, OSHA Standards
Expert provides safety engineering, accident investigation, accident reconstruction, industrial/construction accident consulting, expert witness testimony, and related expertise to a wide variety of clients. In addition to the automotive “Big Three” he was the safety director at a sheet metal stamping…
Environmental Consulting – Industrial Wastewater & Process & Hazardous wastes
Expert has designed and refined and modeled activated sludge processes using a variety of models and have published technical articles on his work. Expert has designed and used air strippers in the treatment of groundwater and for oxidation. He is…
Water Treatment, Corrosion By Waters, Boiler Water Treatment, Cooling Water Treatment, Demineralization, Reverse Osmosis, Clarifiers Cold Lime Softeners
Expert understands the chemical processes and had practical experience in the use of activated carbon in water and wastewater treatment to remove organic contaminants and chlorine. She has audited existing applications for conformance to industry standards for contaminant removal and…
Practical Application of GLP, GCP, and cGMP to Pharmaceutical, Device, and Biotechnology Firms
As Vice President at a pharmaceutical company, Expert formulated eight pharmaceuticals for use in their patented buccal delivery platform technology. Five formulations were acceptable to FDA and were allowed to proceed into human clinical trials under IND controls. Four of…
Biotechnology Product Reviews, Biologics, Drugs & Medical Devices, FDA Litigation, Vaccines, etc.
Over 18 years experience with legal, scientific, business and regulatory issues affecting the research, development and commercialization of biomedical and information security products. Recognized expertise in strategy development, audit and due diligence, outsourcing, and FDA regulatory matters, including consulting for…
Aseptic Process Design, Airflow Visualization, HACCP, PAI Preparation, Cleaning Validation
Expert has performed validation of aseptic processes including technologies such as blow-fill-seal, high-speed automated liquid and powder filling lines, lyophilization, barrier and isolation technology, and bulk pharmaceutical and biological processes. Expert has developed an airflow visualization procedure to assist the…
Environmental Compliance, Pollution Prevention, Health and Safety, and Fire Loss and Prevention
Expert has extensive practical knowledge and experience in the field of pollution prevention technologies. He has performed numerous pollution prevention audits internationally resulting in millions of dollars in waste minimization, energy and feedstock material savings for clients. He has worked…
Contamination Control and Cleanrooms
The relationship between facility cleanliness and product cleanliness, between design criteria and operational conditions is one that even today oftentimes remains a mystery. Particle fallout is the source of visible contamination for contamination sensitive products during storage and assembly. While…