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Sterilization; Food & Drug Product, Packaging & Process Development; HACCP & Validation
Expert is a nationally recognized expert in aseptic, retort and autoclave, thermal processing and associated packaging of foods and drugs. He is well networked with the FDA food regulatory agency technical staff, academia, other process authorities, and research consortia. He…
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…
Pharmaceutical Development & Validation
Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products…
Biotechnology: All Areas of Business and Technology
Expert has extensive hands-on experience with, and knowledge of, deoxyribonucleic acid (DNA) probe technology, having worked in this area for 10 years. He used nucleic acid probe technology to characterize mammalian viruses and oncogenes while performing research supported by the…
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,…
Immunology, Vaccine Research
Expert is an internationally recognized expert in mucosal immunology. He has published more than 70 papers and reviews in several prestigious scientific journals. He is best known for experimentally establishing (with continuing research) the concept of a common mucosal immunologic…
Chronic Respiratory Disease
RESPIRATORY SYSTEM DISEASES; RESPIRATORY SYSTEM DISEASE THERAPY; ALLERGEN. Expert has over 25 years of experience as a clinical allergist specializing in chronic respiratory diseases. He is adept at the use of allergens, histamines and methacholine to document the triggers of…
Medical Device Design and Manufacturing: Laboratory Devices, Surgical Instruments, and Disposables
Expert has expertise in the design and development of laboratory devices, surgical instruments, and disposables for the biotechnology, pharmaceutical, medical device, electronic, cosmetic, and consumer product industries. Examples of products he has developed and/or patented are an I.V. disposable product…
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…
Biomedical Engineering, Manufacturing Engineering, R&D
Expert has over 20 years of experience in the research and development of medical devices for: electrodes for transcutaneous sensing and stimulation (EKG, EEG, EMG, TENS, defibrillation, pacing); respiratory therapy, specifically spirometric measurements, exercizers, and nebulizers; thermometry for clinical applications;…