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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…
Infectious Diseases, Infection Control, Epidemiology, Public Health, and Pediatrics
Expert R. Expert was an author on the Centers for Disease Control and Prevention (CDC) Guideline for Prevention of Transmission of M. tuberculosis in Healthcare Settings and the WHO Guideline for Prevention of M. tuberculosis Transmission in Healthcare Settings in…
Medical Consulting, Preventative Medicine, Cardiovascular Disease
Expert has been interested in clinical medicine throughout his career. He is a Board certified internist, with an active interest in both patient care and research activities. After completing medical school at George Washington University in Washington, DC, he undertook…
Process Engineering, Inorganic Chemicals: Chloralkali, Sulfuric Acid, SO2, and Fertilizers
Expert’s graduate work (M.Sc. and Ph.D.) was in adsorption of gases in molecular sieve zeolites. The work included exhaustive experimentation on equilibrium and kinetics of adsorption and included calculation of adsorption energy from electrostatic and van der Waals forces acting…
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…
Optical Transport Systems, DWDM, OADM, SONET, SDH, Network Design and Implementation
Expert has applied his academic background and deep knowledge of the telecom industry to design systems that support broadband communications. In particular, he was instrumental in the design and implementation of long haul broadband communications networks with transmission speeds of…
Applied Rubber Technology, Design of Experiments, and Training in Both
The primary rubber-forming process he works in is molding, including compression, transfer, and injection methods. His experience with molded products is broad, including automotive weather strip, milking inflations, various types of vibration mounts, seals, diaphragms, aerospace components, vehicle tracks, and…
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…
Chemical Plant Manufacturing, Process Development, Polyester Polymer, Polyester Film Coating
Expert has extensive experience working in chemical plant manufacturing at several DuPont facilities: Niagara Falls, NY; Victoria, TX; Savannah River, SC; Cape Fear, NC; Sabine River, TX; and Florence, SC. He has always worked in a technical role in manufacturing…
Thin Film Solar Cell Testing; Semiconductor Optoelectronic Device Measurement and Analysis
Expert has been involved in research and development of amorphous silicon (a-Si) thin film solar cells for 20 years; in this time he has authored or co-authored over 30 papers. He has guided the optimization of device performance from three…