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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…
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…
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,…
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…
Membranes, Filters, Separations, Validation, Extractables, Leachables
Expert was responsible for building a new manufacturing facility for hollow-fiber thin film composite membranes for industrial gas and liquid. He helped design the equipment, created the plant layout, hired staff, and led the trouble-shooting phase. He led the engineering…
Engineering Management
Expert has been involved with the re-engineering of new product development processes, creation of total quality management programs, and organizational structure changes for process engineering and research and development functions for two major medical device manufacturers (i.e. Johnson & Johnson…
Knowledge Management
Expert is a recognized authority in the field of knowledge management. He has created successful knowledge-management solutions for Fortune 500 companies in a wide range of industries. His areas of expertise include knowledge management strategy development, design and implementation of…
Web Coating Technology
Expert has spent over 28 years in the web coating industry. He has experience in wax coating, hot melt, solvent coating, solventless coating, and emulsion coating on a wide variety of webs, from light weight films and foils to SBS…
Registration of Drugs, Medical Devices, Cosmetics,Borderline Products; Reimbursement, expert witness
Expert has more than 30 years experience in the registration of ethical and OTC pharmaceuticals. He has worked with solid dosage forms, aerosols, sterile injectables, vaccines, topical products, and biotechnology products. He has registered new chemical entities, novel dosage forms,…
Plastic Molding Processes
Expert has extensive experience with plastic molding processes and with injection molding in particular. He is often called upon to help clients with issues such as injection molding machine selection, injection mold lubrication, and in-mold labeling. He has been responsible…