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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…
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…
Chemical Manufacturing
Expert has specialized in the design of batch and continuous blending operations typical in the chemical, food, detergent, and personal care products industries. He has developed designs to minimize product aeration and eliminate product storage equipment. He has designed solid…
Environmental, Health and Safety Project Engineering Management; Complex Legal Chemical Circumstances
Expert specializes in providing expert legal opinions and due diligence consulting with a strong emphasis on chemicals, equipment use, environmental and safety related best management practices, employee safety, effect of chemicals, installation of equipment and his knowledge of equipment and…
Mixing, Pilot Plants, Scaleup, Atomization, Agglomeration, Evaporation, Heat Exchangers
Expert has extensive knowledge of mixing operations needed in the chemical, petrochemical, and biochemical industries. His knowledge includes the proper selection of effective mixing geometries and the power requirements needed by a mixing unit in either laminar or turbulent applications.…
Synthesis and Characterization of Ceramic Powders and Single Crystals
Expert has used microencapsulation as a method to prepare multicomponent ceramic powders containing two to five components. He developed (and is in the process of patenting) the first dry microencapsulation process that also can be used as a granulation method.…
Materials (grain, fertilizer, rock, coal, wood chips, etc.) Handling, Storage and Processing. Facilities, Bins, Silos, Mills and Related Equipment and Processes
Expert has expertise in bulk materials handling, storage, and processing systems particularly in regard to the agricultural industry. He specializes in the structure and systems design of pre-engineered buildings, bins, silos, and bunkers. He has experience in the specification, design,…
Pharmaceutical Technology, Manufacturing, Quality Systems and Regulations; GMPs and GLPs
Expert specializes in the field of pharmaceutical technology with particular emphasis on the development, manufacture, quality control and quality assurance of pharmaceuticals and medical devices. As a professional consultant to the healthcare manufacturing industries, he works with about 30 worldwide…