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Expert in Analytical Chemistry and FDA, CMC, and Regulatory Issues
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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analysis technique expert
analyte expert
analytical chemistry expert
analytical monitoring expert
analytical reagent expert
polymer characterization expert
optical instrument expert
atomic emission spectroscopy expert
optical spectroscopy expert
optical test expert
spectroscope expert
thermal test expert
photometry expert
analytical testing expert
optical instrumentation expert
material analysis expert
atomic absorption spectroscopy expert
chemical testing laboratory expert
analytical test expert
analytical chemistry instrument expert |
Expert spent over 22 years as Manager of the Analytical Chemistry Department and the Polymer Characterization Center at a major company. He is knowledgeable in all aspects of analytical chemistry, instrumental analysis, and polymer characterization techniques. He has been an instructor in a training course for laboratory workers in a GMP environment. He is the author of two chapters in the acclaimed text, “Analytical Chemistry in a cGMP Environment.” He is a trained molecular spectroscopist having published on IR and Raman spectroscopy. |
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Food and Drug Administration regulation expert
Chemistry, Manufacturing and Controls expert |
Expert is experienced with FDA regulations as applied to medical devices and pharmaceuticals. He is a trained lead auditor for ISO certification and has performed numerous laboratory and manufacturing site audits for ISO and FDA cGMP compliance. He has assisted a number of clients in writing CMC sections of NDAs and INDs. |
| Show Secondary and Basic Areas of Expertise |
Localities:
Expert may consult nationally and internationally, and is also local to the following cities: New York, New York; Yonkers, New York; Newark, New Jersey; Jersey City, New Jersey; Paterson, New Jersey; Elizabeth, New Jersey; Bridgeport, Connecticut; New Haven, Connecticut; Stamford, Connecticut; and Philadelphia, Pennsylvania.
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| Year |
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Degree |
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Subject |
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Institution |
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Honors |
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1968
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Ph.D.
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Physical Chemistry (Spectroscopy)
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University of Maryland
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1964
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M.S.
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Chemistry
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Northeastern University
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1959
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B.S.
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Chemistry
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Brooklyn College, CUNY
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Cum Laude
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| Years |
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Employer |
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Department |
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Title |
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Responsibilities |
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1994 to
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(Undisclosed Consulting Company)
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Technical Consultant
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Expert is responsible for providing consulting services to clients in FDA regulated industries. Services include CMC submissions, quality audits, testing, and characterization methods.
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1994 to
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(Undisclosed Consulting Company)
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Technical Advisor
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He provides consulting services relating to chemistry issues for FDA-regulated companies.
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2002 to 2003
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William Paterson University
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Chemistry & Physics
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Adjunct Professor
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Expert taught the course “College Chemistry for Science Majors.” Instruction included lectures and laboratories.
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1972 to 1994
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Ethicon Inc.
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Research
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Manager/Director
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He directed the activities of the Chemistry Department and the Polymer Characterization Center for Johnson & Johnson.
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1969 to 1972
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Allied Chemical Corp.
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Research Scientist
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Expert developed infrared and Raman spectroscopic methodologies to characterize polymeric materials.
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1960 to 1964
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Avco Corporation
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Materials Department
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Research Scientist
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He developed methodologies to characterize aerospace materials at high temperatures.
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Associations/Societies
Expert is a member of ACS, AAAS, the Coblentz Society, AMS, ASTM, Society for Sigma Xi, NATAS, and AAMI.
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Licenses/Certifications
He is a Certified Lead Auditor for Quality Systems.
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Professional Appointments
Expert was the Chairman of the American Microchemical Society from 2001-2003. He is a member of the Governing Board of the Eastern Analytical Symposium.
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Awards/Recognition
He recived the Johnson & Johnson Distinguished Service Award.
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Publications and Patents
Expert is the author of over 35 publications in peer-reviewed journals, the editor of two books, and a contributing author of two chapters in a recent book on analytical chemistry in a GMP environment.
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| Government Experience: |
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Agency |
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Role |
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Description |
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1959 to 1959
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U.S. Atomic Energy Commission
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Radiation Chemist
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Expert performed radiochemical analyses to determine the level of activity as a result of nuclear atmospheric testing.
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Expert performed quality audits to determine the compliance of a pharmaceutical company with FDA requirements.
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He provided writing services to bring standard operating procedures into proper formatting for a quality system.
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Expert helped to assemble the CMC section of a New Drug Application to the FDA.
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He helped in understanding a problem with the measurement of a polymeric material. He modified a test procedure and arranged for validation.
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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 Analytical Chemistry Consultant and FDA Consultant, CMC Consultant, Consultant and Regulatory Issues 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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Expert gave a deposition as an expert witness for the plaintiff in a product liability case against a medical device manufacturer. He also provided expert advice to a legal team representing a major drug manufacturer in a patent litigation.
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 Analytical Chemistry Expert Witness and FDA Expert Witness, CMC Expert Witness, Expert Witness and Regulatory Issues 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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1996 to 1996
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Pakistan
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Expert was part of a team that instructed companies in the medical device industry on becoming registered with the FDA.
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2000 to 2000
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Argentina
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He helped bring a manufacturer of an active pharmaceutical ingredient into FDA compliance.
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| Language Skills: |
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| Foreign Language |
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Description |
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German
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Expert can read with some understanding of important aspects.
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French
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He can read with some understanding of content.
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Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Analytical Chemistry and FDA, CMC, and Regulatory Issues.
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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Training/Seminars
He developed a series of seminars on polymer characterization presented to J&J employees. He also developed lectures in statistics and spectroscopy presented as part of a certification program for analysts within J&J.
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Supplier and Vendor Location and Selection He has assisted companies in locating suppliers of laboratory services and instrumentation in the pharmaceutical and medical device industry.
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Expertise
