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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…
Plastic and Coating Stabilization; Controlled Degradation Analysis and Design; Analytical Services
Expert's knowledge in the area of amorphous and crystalline polymers is based on 36 years in the field, having worked with all commercially available amorphous, crystalline, and semicrystalline resins. His knowledge includes physical properties and stabilization at many levels and…
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…
Corrosion and Metallurgical Failure Analysis
Expert notes that corrosion is a major problem that affects many industries. Expert has spent over forty years studying and solving corrosion problems in the construction, aerospace, defense, petroleum, utility and related industries. He was also the technical editor of…
Nondestructive Testing and Evaluation; Machine and Structural Design
Expert has been at (Undisclosed) where he currently is a professor in the Department of General Engineering. Expert is also Director of the Nondestructive Testing and Evaluation Research Laboratory. The Laboratory supports research work in ultrasonics (immersion, air-coupled, and water-squirt),…
Facilitating Business Growth Through Commercialization of New Medical and Biotechnology Products
Expert has extensive experience supporting clients in pharmaceutical, medical and industrial markets. An electrical engineer by training, and the principal of his own consultancy for more than 12 years, he brings strong market, business development and technical skills to his…
Environmental Chemistry: Analytical, Fate and Transport, Statistics, Validation, Data Management
Fundamental to almost every decision made in the environmental sciences are chemical analytical data describing the nature and extent of contamination or monitoring and environmental process or condition. It is rare, however, to find individuals who understand chemical analytical data…
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst,…
Biomaterials and Product Development R&D for Orthopedic, Cardiovascular, and Other Implants
Expert has helped assemble, and been lead author on 510(k) and IDE applications to the FDA. This has often included telephone conversations, and occasionally personal visits, with the FDA to discuss unique aspects of the devices and/or materials in the…
Drinking Water Quality
In his work with water quality, he was responsible for the interpretation of and compliance with the Surface Water Treatment Rule, the Coliform Rule, the Disinfection/Disinfection By Products Rule, the Lead and Copper Rule, and the Radionuclides Rule. By virtue…