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Expert in Endotoxin Detection and Removal
Available for your Consulting and Expert Witness Needs
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| Summary of Expertise: |
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Primary Expertise Areas:
(links show more experts in each area)
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Expertise Description: |
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bacterial endotoxin expert
depyrogenation expert
endotoxin detection expert
endotoxin removal expert
FDA limulus amoebocyte lysate test regulation expert
limulus amoebocyte lysate test expert
pyrogen expert
United States Pharmacopeia biological safety testing expert
USP limulus amoebocyte lysate test regulation expert |
ENDOTOXIN DETECTION; LAL TEST. Expert was associated with the Baxter Healthcare Corporation's Limulus amoebocyte lysate (LAL) and rabbit pyrogen testing program for more than 20 years. During that time, she was involved in validating LAL test methods for hundreds of raw materials, large and small volume parenteral drugs, biological products, and medical devices. She is especially skilled in overcoming LAL inhibition/enhancement problems and false positive LAL test results related to non-endotoxin LAL-reactive materials. ENDOTOXIN REMOVAL OR DESTRUCTION (DEPYROGENATION). In her consulting practice, Expert is frequently asked to assist customers in removing endotoxin contaminants from products or from product manufacturing processes. Endotoxin contamination is especially prevalent with products derived from recombinant processes utilizing E. coli organisms (endotoxin-producers). She is also experienced in validating depyrogenation processes. MEDICAL DEVICE ENDOTOXIN DETECTION. Expert is knowledgeable of all areas of endotoxin detection by various LAL, rabbit, and cytokine tests. She can detect false positive results and can help validate tests for new products. USP AND FDA LAL TEST REGULATIONS. As a member of several inter-industry task force groups, Expert has actively participated in inter-industry collaborative studies that have shaped the United States Pharmacopeia's (USP) <85> Bacterial Endotoxins Test and the Food and Drug Administration's (FDA) LAL Test Validation Guideline. In her consulting practice, Expert frequently helps customers respond to FDA 483 citations and initiate programs to comply with regulatory requirements. LAL AND PYROGEN TEST TRAINING. Expert has conducted LAL training workshops for several inter-industry organizations. She has delivered lectures and seminars for customers and universities on topics related to endotoxin, LAL testing, and depyrogenation. She is also experienced in preparing and/or evaluating standard procedures for pyrogen or endotoxin testing. USP BIOLOGICAL SAFETY TESTING. Expert was actively involved for many years in the application of USP biological safety tests. These encompassed the safety evaluation of parenteral drugs and medical devices.
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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: Chicago, Illinois; Rockford, Illinois; Aurora, Illinois; Naperville, Illinois; Joliet, Illinois; Elgin, Illinois; South Bend, Indiana; Gary, Indiana; Milwaukee, Wisconsin; and Madison, Wisconsin.
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Degree |
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Subject |
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Institution |
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1981
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MBA
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Management
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Lake Forest School of Management
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1962
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MS
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Anatomy/Histology
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University of Illinois
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1960
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BA
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Biology
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Valparaiso University
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| Years |
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Employer |
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Title |
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Responsibilities |
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1990 to
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(Undisclosed Consulting Company)
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President & Principal Technical Consultant
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Owner and principal consultant in the pharmaceutical and medical device industries for pyrogen and endotoxin detection and elimination.
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1989 to 1990
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Baxter Healthcard Corporation
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Senior Research Scientist
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1962 to 1989
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Baxter Healthcare Corporation
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Various positions
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Associations/Societies
Expert is a member of the Parenteral Drug Association (PDA), the International Endotoxin Society, the LAL Users Group, and the New York Academy of Science.
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Professional Appointments
She was appointed to the USP Export Advisory Panel on Microbiological Control and Process Validation in 1995.
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Awards/Recognition
Expert received the Outstanding Technical Award from Baxter Healthcare Corporation, Applied Sciences Division.
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Publications and Patents
She holds a patent for an "Improved Method of Nephelometrically Determining Endotoxin Concentration." She has lectured world-wide and authored or co-authored numerous publications on the subject of pyrogen testing and was co-author of the "Guideline for the Use of the Limulus Lysate Test for Pyrogen Testing Medical Devices" (HIMA Report 78-8).
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She frequently travels to the customer's site to evaluate manufacturer's processes for endotoxin contamination potential.
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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 an Endotoxin Detection Consultant and Removal 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.
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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 an Endotoxin Detection Expert Witness and Removal 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.
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| International Experience: |
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Country / Region |
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Summary |
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1990 to
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Malaysia
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She performed an evaluation of medical device facility for capability of manufacturing non-pyrogenic devices.
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1993 to
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Ireland
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She performed an examination of medical device facility to recommend ways to eliminate or reduce bioburden and endotoxin contamination.
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Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Endotoxin Detection and Removal.
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.
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| Additional Skills and Services: |
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Supplier and Vendor Location and Selection Expert has experience in locating vendors of ndotoxin detection reagents and test systems and
endotoxin removal devices and materials. She has access to the following resources to aid in vendor location: printed materials and personal contacts.
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Expertise
