|
|
Expert in Medical Device Sterilization
Available for your Consulting and Expert Witness Needs
|
|
|
 |
| Summary of Expertise: |
 |
Primary Expertise Areas:
(links show more experts in each area)
|
Expertise Description: |
|
medical sterilization expert
biologic sterilization expert
irradiation sterilization expert
electron-beam sterilization expert
cobalt-60 sterilization expert
ethylene oxide sterilization expert |
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). |
|
medical device sterility expert
medical device sterilization expert
medical device irradiation sterilization expert |
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. |
|
medical device process validation expert
process validation expert
aseptic pharmaceutical process validation expert |
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. |
|
sterilization expert
sterility expert |
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. |
|
surgical product expert
medical instrument sterilization expert |
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. |
|
diaper expert
superabsorbent polymer expert |
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. |
| 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.
|
| Year |
|
Degree |
|
Subject |
|
Institution |
|
|
1953
|
|
Ph.D.
|
|
Microbiology
|
|
Syracuse University
|
|
|
1951
|
|
M.S.
|
|
Bacteriology
|
|
Syracuse University
|
|
|
1947
|
|
B.S.
|
|
Biology, Chemistry
|
|
University of Scranton
|
|
| Years |
|
Employer |
|
Title |
|
|
1990 to
|
|
(Undisclosed)
|
|
Independent Consultant
|
|
|
1980 to 1990
|
|
Wyeth Laboratories (American Home Products)
|
|
Head of Process Validation
|
|
|
1978 to 1979
|
|
Pollak and Skan, Inc.
|
|
Technical Director and Consultant
|
|
|
1972 to 1979
|
|
Parke, Davis & Co.
|
|
Director of Research and Development
|
|
|
1962 to 1972
|
|
Ethicon, Inc. (Johnson & Johnson)
|
|
Research Manager
|
|
|
1957 to 1962
|
|
Bristol-Myers Co.
|
|
Scientist-in-Charge of Microbiology-Bacteriology
|
|
|
1953 to 1957
|
|
Wallace & Tiernan, Inc.
|
|
Head of Biology Laboratories
|
|
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.
|
Professional Appointments
He is also the Past President and Vice President of the New Jersey Chapter of the American Society of Microbiology.
|
| Publications: |
|
Publications and Patents Summary
Expert has authored more than 50 technical publications.
|
|
Selected Publications and Publishers
|
|
|
- Philadelphia Discussion Group, Academy of Pharmaceutical Sciences
|
|
|
- Annual Conference Association of Official Analytical Chemists
|
|
|
- Pergamon Press
|
|
|
- Dowden, Hutchinson & Ross
|
|
|
- Quality Control in the Pharmaceutical Industry
|
|
|
Recent Client Requests:
|
-
Sterilization expert for consulting on sterilization opinion/justification letter.
-
ETO sterilization expert for professional opinion on instruction booklet.
-
FDA sterile medical device regulatory expert for consulting on sterile package integrity validation.
-
Expert in medical devices for consulting on sterile technique.
-
FDA analytical expert needed for consulting on HPLC methods for FDA review.
|
As a member of the Intota consultant network,
Expert is a specialist who provides technical consulting to corporate, legal and government clients. Expert provides professional consulting as a Medical Device Sterilization Consultant. Expert may consult as an independent consultant or as a member of a consultancy, consulting company,
or consulting firm. Consultants service will be covered by a consulting contract.
Ask an expert initial screening questions and ask the experts services particulars, by simply submitting
an expert request.
|
|
Recent Litigation Client Requests:
|
-
medical & sterilization expert for consulting on proper sterilization techniques.
-
FDA and medical device expert for consulting on a medical malpractice case.
-
Expert in medical device sterilization for consulting on reviewing medical implant equipment.
|
Intota experts can serve as expert witnesses or litigation consultants offering expert testimony, expert advice, litigation support,
forensic services, and related expert witness services. Expert can serve as an expert witness or litigation consultant in intellectual property (patent, trademark, trade secret, copyright),
product liability, and insurance matters. Expert may provide forensic expert witness testimony, litigation consulting services, forensic investigation,
and forensic testing if appropriate in litigation areas as a Medical Device Sterilization Expert Witness.
Intota provides attorneys and legal professionals the opportunity to ask an expert initial screening questions and
ask the experts services particulars by submitting an expert request.
|
| International Experience: |
|
| Country / Region |
|
Summary |
|
Western Europe
|
|
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.
|
| Language Skills: |
|
| Foreign Language |
|
Description |
|
Ukrainian
|
|
Expert is fluent in the Ukrainian language.
|
|
German
|
|
He can read and write German.
|
|
French
|
|
He also reads and writes French.
|
|
Polish and Russian
|
|
And he can read Polish and Russian.
|
|
Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Medical Device Sterilization.
Experts are an invaluable source of overall industry insight as well as insight into specific companies and firms for
custom business to business (b2b) and industrial market research. Intota uses analyst and
consultant resources from Guideline whose Research Directors manage the research and analysis of the qualitative
and quantitative data as well as report writing for the custom studies. The methods and tools
used by Intota market research combine the insights of technical experts and industry insiders with secondary
research to provide the custom b2b and industrial market research you need.
|
|
Expertise
