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Expert in Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals
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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Food and Drug Administration expert
Chemistry, Manufacturing and Controls expert |
Expert retired in 1992 from the FDA after a 29-year career. He spent his career in the FDA as a field laboratory analytical Chemist, a scientific coordinator in the management of Quality Assurance programs for field scientists, a program analyst, an editor of various analytical manuals, as a Chief Chemist in charge of supervising review chemists/microbiologists in the review and approval of CMC sections for veterinary drug products. His last position was that of Staff Scientist for Manufacturing and Quality Control on the Generic Animal Drug and Quality Control Staff in the Center for Veterinary Medicine. Expert served as a member of the USP Revision Committee from 1980 to 1990. He has served as a member of the AFIA Aquaculture Committee and Working Group (1993-1996). |
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Good Manufacturing Practice expert
standard operating procedure expert
veterinary medicine expert
Food and Drug Administration regulation expert
Food and Drug Administration compliance expert
Food and Drug Administration National Drug Code expert |
Since 1992 he has worked as a consultant to the pharmaceutical industry for human and veterinary products. He is knowledgeable in the development of SOPs for GMP operations (human, veterinary and animal products), stability and method validation protocols. He has conducted GMP audits of bulk pharmaceutical chemicals (APIs) and dosage form manufacturing sites and operations, both foreign and domestic. He has also conducted GLP audits. Now he focuses on providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs. |
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animal drug testing expert
veterinary pharmacology expert |
As a Staff Scientist at the Office of New Animal Drug Evaluation Center for Veterinary Medicine, he helped to develop international and FDA-industry Guidelines, he coordinated the Office-FDA Field/Foreign Inspections of Veterinary Manufacturing sites, and the CVM-Field Bio-Monitoring Research Activities. He also provided guidance in the review of Animal Drug Applications. From 1975 to 1990, he was the Manager of the Manufacturing and Quality Control Unit in the Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation, Center for Veterinary Medicine. There, he managed the reviews of manufacturing sections of New Animal Drug Applications, provided Quality Control to assure consistency of review, met with industry representatives to discuss applicable sections of NADA submissions, developed of guideline (stability and manufacturing) and conduct of training, and was Co-Editor of the Animal Drug Analytical
manual. |
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food additive expert
pesticide expert
pesticide toxicity expert |
As an Analytical Chemist in the FDA Cincinnati District Office, he conducted analyses of human (pharmaceutical) and veterinary (pharmaceutical and medicated feeds) drugs, foods for food additives, pesticides in foods, drug residues, controlled and narcotic drugs, hazardous substances; and conducted research into the development of methods for laboratory use.
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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: Baltimore, Maryland; Frederick, Maryland; Gaithersburg, Maryland; Bowie, Maryland; Richmond, Virginia; Alexandria, Virginia; Wilmington, Delaware; and Lancaster, Pennsylvania.
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Subject |
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Institution |
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BS
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Chemistry
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Wheeling Jesuit University
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Graduate Study-Advanced Chemistry
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Cincinnati University
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Advanced Analytical Chemistry
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Georgetown University
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Food and Drug Law
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George Washington University
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| Years |
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Responsibilities |
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1997 to
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(Undisclosed Consulting Company)
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Senior Consultant
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Responsibilities include providing advice and assistance in the areas of human drugs and devices, and veterinary products. Particular focus is given to areas of GMPs, audits and regulatory affairs.
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1996 to 1997
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Independent Conultant
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Consultant to the Pharmaceutical Industry
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Responsibilities included providing advice and assistance in the areas of regulatory affairs, cGMP requirements, development of SOPs and validation protocols.
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1992 to 1996
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PennField Oil Co., Omaha, Nebraska
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Vice President for Government and Regulatory Affairs
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Responsibilities included overseeing that operations at POC complied with FDA, EPA, and OSHA regulations; developing of SOPS and protocols; conducting visits of Foreign manufacturers (APIs) of POC products; conducting mock inspections of POC site and New Drug Substance manufacturing sites.
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1990 to 1992
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FDA
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Office of New Animal Drug Evaluation Center for Veterinary Medicine
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Staff Scientist, Manufacturing and Quality Control Generic Animal Drug and Quality Control Staff
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1975 to 1990
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Center for Veterinary Medicine, FDA
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Division of Chemistry in the Office of the Director, Office of New Animal Drug Evaluation
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Manager (Branch Chief, Supervisory Chemist and Chief Chemist)
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1967 to 1975
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FDA
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Division of Field Operations in the office of the Executive Director for Regional Operations
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Scientific Coordinator–Chemist in the Field Sciences Branch
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Responsibilities included coordinating/managing analytical activities of FDA field Scientists relative to the conduct of responsible FDA field and headquarters program activities: coordinating analytical methodology and quality control functions; coordinate test of new human and veterinary drugs and food additives as presented in formal applications; conducting training exercises and developing methodology as needed; editing of Food Additive and Animal Drug Analytical manuals.
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1962 to 1967
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FDA
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Cincinnati District Office
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Analytical Chemist
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Associations/Societies
He is a member of the American Chemical Society, the
Parenteral Drug Association, and the
Regulatory Affairs Professional Society.
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Publications and Patents
He is the author of several publications.
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| Government Experience: |
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Agency |
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1962 to 1992
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FDA
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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 a Veterinary Drugs Consultant, Veterinary Pharmaceuticals Consultant, Animal Drugs Consultant, Animal Pharmaceuticals 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 a Veterinary Drugs Expert Witness, Veterinary Pharmaceuticals Expert Witness, Animal Drugs Expert Witness, Animal Pharmaceuticals 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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Expert serves as a resource to
Intota Market Research Services
for customized marketing research in industries or areas related to
Veterinary Drugs, Veterinary Pharmaceuticals, Animal Drugs, Animal Pharmaceuticals.
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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Expertise
