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Medical Devices, Biotech, Aseptic Processing, Engineering, Facilities, and Sterilization
Expert has extensive expertise in all areas of aseptic processing and terminal sterilization of medical devices, human tissue for transplanation processing, microcontamination and controlled environments. He has been involved in clean room projects for Ethicon, Inc., Osteotech, Inc., Manufacturing Automation…
Records Management, Information Governance, International Record Retention, Digital Document Management, Email Management
Records Management; Document Management; Electronic Records: For over 40 years Expert has been involved with records and document management activities as a professional practitioner, consultant, teacher, researcher, and writer. He has extensive experience developing information and records management policies, strategic…
Blood Wetted Devices and Biomaterials
BLOOD-WETTED BIOMATERIAL; CARDIOVASCULAR PROSTHESES; ARTIFICIAL INTERNAL ORGANS. Expert has been involved in the design, development, and evaluation of extracorporeal and implantable artificial internal organs for many years, first with the artificial kidney (including hemodialyzers and those based upon selective absorption)…
Auditory Bioengineering, Sensory Aids, Hearing Loss, Passive & Active Protectors
Expert's main expertise lies in applying the combination of hearing science, audiology, and electrical engineering to the functional design of devices for the normal or impaired ear. This includes research on speech processing to improve understanding by the hearing impaired;…
Molecular Biology, Molecular Pathology, Polymerase Chain Reaction Technology
Expert has expertise in the adaptation and development of molecular biological techniques to answer medical questions of human genetics, differential gene expression, diagnostics, epidemiology, and pathogenesis, particularly in regard to infectious agents and genetic diseases. The CGS is a multidisciplinary…
Medical Technology
A significant portion of Expert's current activities include maintaining awareness and working knowledge of regulations that impact medical device manufacturers. She has specific experience with new medical device submissions, including combination products. Expert is proficient in total quality systems requirements…
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…
Biocides, Industrial Antimicrobial Agents
INDUSTRIAL MICROBICIDES. The areas of Expert' greatest current activity and most significant career experience and expertise are the product development and application of industrial antimicrobial agents. He provides expert technical assistance in the chemistry and microbiology necessary to the selection…