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Expert in Medical Device Sterilization
Available for your Consulting and Expert Witness Needs
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Summary of Expertise:
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Listed with other top experts in: |
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Expert is an expert in medical device sterilization. He has advanced technical knowledge in all phases of sterilization, including work with heat, chemical, and irradiation sterilization processes. He is especially adept with the irradiation processes involving electron beams and cobalt-60. Expert has been recognized as conducting pioneering work on medical device sterilization with cobalt-60 and ethylene oxide. He was the editor of the text "Chemical Sterilization," and has authored numerous publications in this area (see "Publications" section below).
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Expert has extensive experience with all phases of sterility and aseptic techniques. He was responsible for the development and quality assurance of various products in the pharmaceutical, cosmetic, and medical device industries. He is a member of the US Pharmaceutical Bio-Indicator Panel and author of "Sterility Testing of Pharmaceuticals, Cosmetics, and Medical Devices" in the text Quality Control in the Pharmaceutical Industry.
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As the Technical Director and Consultant for Pollak and Skan, Inc., Expert worked extensively with process validation techniques and procedures. He also initiated new process validation programs for various divisions within American Home Products and was responsible for validation in all production phases.
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Expert was part of a team at Ethicon, Inc. that introduced a new chemical sterilizing agent called "cidex." He worked closely with USDA personnel to gain this product's government approval. He also assembled a team of microbiological sterilization experts to work with the FDA for approval of a chemical sterilizing solution for soft contact lenses.
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As Director of Research and Development for the Parke-Davis Medical Surgical Division, Expert was responsible for the introduction of new products for the hospital operating room environment. The products he has worked with include surgical sponges, support hose, orthopedic appliances, bandages, bed pads, and others. He was the first to introduce incontinent pads and diapers with absorbent polymeric materials, which has now become a multi-million dollar industry.
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Expert has developed products used by patients with urinary dysfunction. He has added polymer to diaper and hospital bed pad materials that could absorb more than 100 times its weight in liquids. This work was conducted in the early 1980s, prior to the development of popular commercial products on the market today.
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Show Secondary and Basic Areas of Expertise | Localities:
Expert may consult nationally and internationally, and is also local to the following cities: Atlanta, Georgia;
Augusta, Georgia;
Athens, Georgia;
Roswell, Georgia;
Asheville, North Carolina;
Gastonia, North Carolina;
and Greenville, South Carolina.
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Degree |
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Subject |
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Institution |
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1953
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Ph.D.
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Microbiology
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Syracuse University
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1951
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M.S.
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Bacteriology
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Syracuse University
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1947
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B.S.
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Biology, Chemistry
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University of Scranton
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Employer |
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Title |
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1990 to
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(Undisclosed)
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Independent Consultant
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1980 to 1990
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Wyeth Laboratories (American Home Products)
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Head of Process Validation
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1978 to 1979
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Pollak and Skan, Inc.
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Technical Director and Consultant
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1972 to 1979
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Parke, Davis & Co.
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Director of Research and Development
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1962 to 1972
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Ethicon, Inc. (Johnson & Johnson)
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Research Manager
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1957 to 1962
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Bristol-Myers Co.
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Scientist-in-Charge of Microbiology-Bacteriology
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1953 to 1957
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Wallace & Tiernan, Inc.
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Head of Biology Laboratories
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Associations/Societies
Expert is a past member of the American Society of Microbiology, the American Chemical Society, AAAS, the New York Academy of Science, and the Biomaterials Society.
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Professional Appointments
He is also the Past President and Vice President of the New Jersey Chapter of the American Society of Microbiology.
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| Publications: |
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Publications and Patents Summary
Expert has authored more than 50 technical publications.
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Selected Publications and Publishers
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- Philadelphia Discussion Group, Academy of Pharmaceutical Sciences
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- Annual Conference Association of Official Analytical Chemists
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- Pergamon Press
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- Dowden, Hutchinson & Ross
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- Quality Control in the Pharmaceutical Industry
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Recent Client Requests:
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Expert for consulting on Validation of sterilization according to ISO 11137.
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Autoclave expert for consulting on Review & Evaluate our current Autoclave Validation Process.
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Sterilization expert for consulting on sterilization opinion/justification letter.
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ETO sterilization expert for professional opinion on instruction booklet.
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FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
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Expert in medical devices for consulting on sterile technique.
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Expert in Gamma and Ethylene Oxide Sterilization.
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FDA analytical expert needed for consulting on HPLC methods for FDA review.
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Sterilization expert autoclave for consulting on Re-useable Medical Device.
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Expert for consulting on Sterilization for Orthopedic Implants.
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Sterilization process expert for consulting on Develop Sterilization Protocols.
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Expert sterilization etho for consulting on ETO Sterilization.
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Click the green button above to contact
Expert for a free initial screening call regarding your expert consulting needs.
Expert is available for consulting to corporate, legal and government clients.
Remember, your initial screening call to speak with
Expert is free.
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Recent Litigation Client Requests:
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medical & sterilization expert for consulting on proper sterilization techniques.
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Expert for consulting on the gamma irradiation sterilization process.
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FDA and medical device expert for consulting on a medical malpractice case.
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Expert in medical device sterilization for consulting on reviewing medical implant equipment.
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Click the green button above to contact
Expert for a free initial screening call regarding expert testimony,
litigation consulting and support, forensic services, or any related expert witness services.
A few litigation needs include product liability, personal injury, economic loss, intellectual property
(patent, trademark, trade secret, copyright), and insurance matters. Remember, your initial screening
call to speak with
Expert is free.
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| International Experience: |
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Summary |
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Western Europe
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Expert worked with German, English, Swedish, and French affiliates of Johnson & Johnson, with visits to their respective production plants. He also worked in England for Parke-Davis on new medical devices.
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| Language Skills: |
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Description |
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Ukrainian
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Expert is fluent in the Ukrainian language.
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German
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He can read and write German.
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French
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He also reads and writes French.
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Polish and Russian
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And he can read Polish and Russian.
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Education
