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Injection Molding Thermoplastics, new product development, material call outs, process de-bug
He performs injection molded part design reviews to insure the part is "molder friendly" and highly producible. He can assist with gate location, transition from metal to plastic reviews and optimise cooling for fastest cycles. He can interact with mold…
Cleanrooms, Contamination Control, Ultrapure Media, Qualification and Validation, GMP, AMC
Expert has been active in aersol physics for more than 25 years. His PhD covers also the areas of environmental, indoor and cleanroom aerosols. He worked in a variety of scientific and technical projects covering the health effects of particles…
Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing
12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…
Injection Molding, Training, Material Selection, Part Design Review, In-Mold Instrumentation
Expert has expertise in specifying and implementing VPT (Velocity to Pressure Transfer) techniques via Cavity Pressure and Temperature Transducers for injection molding applications. He is intimately familiar with systems offered by numerous manufacturers and is proficient in implementing processing methodologies…
Process Automation, Robotic Work Cell Design, Mechanical Design, Machine & Product Design, 3D Models
Expert has been involved as lead design engineer and project manager on numerous manufacturing automation projects for more than a decade. These projects have varied from dedicated "hard automation" systems designed specifically for a single product to flexible automation cells…
Baby Diapers, Non-Woven, Absorbent Products, Films, Wipes, and Consumer Tissue & Towel
Has extensive experience in the development and evaluation of absorbent materials of all types for the management of all types of human exudates. This includes cellulose absorbent cores, superabsorbent materials, foams, fibers and non-woven absorbent materials. Has commercialized over a…
Plastics and Medical Device Development, Plastics Processing, Material, Tooling, Failure Analysis
Expert is a huge proponent of concurrent engineering practices. He has helped numerous companies by helping them implement principles of concurrent engineering which requires all the departments from marketing to manufacturing and assembly to work together right from the inception…
Professional QA & Regulatory Compliance for Medical Devices, Plastics Process Qualification
Expert has over 30 years of experience as a quality improvement professional, providing technical and managerial quality systems management. His base is a select group of processes within which we maintain current knowledge and process engineering skills. He offers full…
Parasitology, Immunology, Microbiology, Bioterror Agents, Grant Writing, Med Writing, Expert Witness
Expert has extensive experience in the preparation and submission of 510(k) documents to the FDA for approval of Class II medical devices. His first work in 510(k) preparation and submission was in 1987 for acceptance of a rapid immunoassay for…
Drug Delivery Using MEMS, Ultrasound, Electroporation and Other Engineering Technologies
Expert has been the founder of two novel fields of transdermal drug delivery and has led a paradigm shift from chemical to physical methods to enhance skin permeability. He published the first paper establishing electroporation of skin. Using this approach,…