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Resume of VQL
Consultant
EXPERTISE AND SERVICES
GMP Compliance Auditor, Assessor, FDA Field Investigator, Pharmaceutical GMP Consultant, Specialist, Forensic Analysis Investigation Expert Witness Testimony, Consulting, ServicesExpertise in pharmaceutical GMP compliance audits and assessment, FDA performance audits, new drug and device approval, RX and OTC drug manufacturing.
Extensive knowledge regarding active pharmaceutical ingredient (API) audits, international pre-FDA inspection audits, international API, NDA GMP compliance, IRBs, clinical investigation of drug and device development, and drug inspections.
Additional areas of specialty include quality control manufacturing, GMP regulations, intensified drug inspections (IDIP), ethical drug manufacturing controls, US Food and Drug pharmaceutical GMP requirements, Federal Food and Drug Administration regulatory activities
PRINCIPAL INDUSTRIES SERVED
Biotechnology, Food, Pharmaceutical, Medical
EDUCATION
B.S., University of Manitoba, Winnipeg, Canada
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing GMP compliance consulting, FDA consulting, pharmaceutical GMP consulting, and related expertise to a wide variety of clients
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Pharmaceutical GMP Compliance Auditor, U.S. Food & Drug Administration
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Conducted pharmaceutical GMP compliance audits
Supervisory Investigator, U.S. Food & Drug Administration
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Supervisory Investigator was responsible for 15 FDA Investigators performing audits of Los Angles District based drug and device manufactures and sponsors, study monitors, clinical investigators of drugs and devices seeking new drug/device approval. GMP Compliance Assessment, RX and OTC Drug Manufacturer, GMP Compliance, Active Pharmaceutical Ingredient (API) audit. Overseas experience includes Pre-FDA Inspection Audit, Italy, API, NDA GMP Compliance and Participation in FDA Inspection and API audits at various sites in India, compliance issues with FDA, Puerto Rico, present during an FDA API audit of facility, Romania.
Division of Field Investigations, Drug Expert, U.S. Food & Drug Administration
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Involved in auditing Sponsors, IRBs’, and Clinical Investigators of drugs/devices in all phases of development, conducted numerous drug inspections both in the U.S. and foreign suppliers of both bulk and finished drug products. Responsible for anticipating training needs of FDA Field Investigators to establish course content, training site visits, and arrange for both outside and FDA lectures. Establishment of National Training Courses in Radio-pharmaceuticals, San Francisco; Medical Devices, MPLS, MN; Computer Auditing –NCTR, Pine Bluff, AK; In-vitro Diagnostics, Long Beach, CA; Biotechnology-USC, Los Angeles, CA.
Food and Drug Officer (Division of Radio-pharmaceuticals), Center for Drugs-Office of New Drugs, U.S. Food & Drug Administration
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Reviewed Field Inspection Reports for compliance with GMP commitments for drugs seeking new drug approval
Pharmaceutical GMP Assistance, US, Egypt
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Made numerous trips to Egypt on behalf of the U.S. Government to assist the Federal Egyptian Government to improve their quality control manufacturing compliance to pharmaceutical GMPs. Conducted various inspections of ethical drug production by both foreign national companies, and Egyptian national manufacturers to assess industry compliance with GMP regulations.
Field Investigator/Drug Specialist (San Francisco District), U.S. Food & Drug Administration
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Conducted a variety of drug and device inspections assessing industry compliance with various GMP Regulations, intensified drug inspections (IDIP) within the San Francisco District, detailed to Chicago District for a 3 month period to assist in the intensified inspection of major pharmaceutical firms located in the Chicago District. Involved in auditing drug clinical investigations conducted in CA state prisons, and at various hospitals and university locations in the San Francisco District.
ADDITIONAL EXPERIENCE
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Food and Drug Directorate, Canadian Federal Government
Conducted inspection services equivalent to the U.S. Food Administration
World Health Organization
Worked with WHO, and was stationed in Zambia, Africa, to write legislation for that country on ethical drug manufacturing controls. Consultant for WHO, traveling to and develop drug legislation for Nigeria, Africa.
Attended and participated in numerous seminars related to GMP requirement for drug and devices, made presentations on FDA SMP requirements to the regulated industry
Independent Consultant contractor associated with a major national consulting firm involved in assisting firms to meeting US Food and Drug pharmaceutical GMP requirements, experience in Federal Food and Drug Administration regulatory activities. Employed by the U.S. Food and Drug Administration, prior employment history in the Canadian Federal Food and Drug Directorate. Supervisory Investigator in the Los Angeles District, monitored and guided the activities of 15 investigators involved in inspections relating to GMP Compliance. FDA Field Investigation Division as the FDA Headquarters Pharmaceutical GMP expert with a special expertise in manufacturing and compliance concerns for Radio Pharmaceuticals.
HONORS AND AWARDS
U.S. Food & Drug Administration Award of Merit
Commendable Service Award
Employee Recognition Award, U.S. Food & Drug Administration
U.S. Food & Drug Administration Commissioner Letter of Appreciation, Egyptian Activities
Numerous Los Angeles District Performance Awards, U.S. Food & Drug Administration
PROFESSIONAL AFFILIATIONS
PDA
Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.
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Kevin Kennedy & Associates, Inc.
Rapid Response Engineering® Solutions
3905 Vincennes Road, Suite 320
Indianapolis, Indiana 46268
(317) 536-7000 voice
(317) 536-7220 fax