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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…
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…
Safety Management in Industry and Construction
At Abbott Laboratories (Ireland) Expert A. Expert served as the chief technical resource for the sterilization of medical devices by ionizing radiation (gamma) and ethylene oxide (EO). He was directly responsible for certification and validation of a number of gamma…
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…
Projects & Technologies for the Power & Process Industries
Expert has long association and experience with marketing and commercialization of new chemical process technologies, management, and engineering design and construction. He has provided expert services in approximately 20 legal and industrial insurance cases. Expert earned his bachelor of science…
Fatigue of Elastomers
Expert managed a tire components development group for a major synthetic rubber supplier for 15 years. During this time he personally established a state-of-the-art fatigue laboratory to assess the fatigue crack growth resistance of various elastomers, compounds, and blends of…
Proposals, RFP analysis, training videos, books and documentation, MVC C Sharp
Expert is a certified Project Management Professional (PMP). He has been a Sr. Program Manager or CTO for several Fortune 500 companies supporting multi-million dollar programs for several agencies within the Intelligence Community and the Department of Defense. He has…
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…
Competitive Intelligence, Doing Business in Japan, B2B Market Research, Strategic Market Planning
Through Expert's consulting activities, he has assisted clients in developing strategies for new business, product and market opportunities. The basis of these efforts has been to conduct market research on a topic and develop a fact base driven against selected…
Proven Methods for Building an Enduring Capability for Faster, Better Product Development
Expert has been influential in helping management improve "time to market" since 1984. He has guided manufacturers in many industries to develop integrated product development (IPD) systems, also known as concurrent development. Through analysis of a specific product development organization,…