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Resume of NPC
Consultant
EXPERTISE AND SERVICES
Chemist, FDA Management and Compliance Expert, Medical Device Compliance Inspector, Drug Manufacturing Compliance Investigator, Biotech Assessment Auditor, Forensic Analysis Consultant, Product Liability, Expert Witness Testimony, Consulting ServicesExpertise in process validation, sterilization processes, cleanrooms, aseptic processes, conducting audits of drug and medical device manufacturers and of their suppliers. Has performed assessment audits of sterile drug manufacturers, biotech facilities and medical device manufacturers. Also has performed drug inspections for compliance to GMPs, ANDAs and NDAs and other requirements.
This KKAI Associate specializes in sterilization processes, field investigation in biologics, medical devices and foods. Has provided expert testimony in legal proceedings before federal grand juries and at trial proceedings. Has conducted regulatory inspections at registered drug and medical device manufacturing firms. Has extensive experience in quality assurance in the areas of drugs, chemicals, pharmaceuticals and medical devices
PRINCIPAL INDUSTRIES SERVED
Medical Manufacturing, Chemical, Pharmaceutical, Government, Legal
EDUCATION
M.S., Management of Public Services, De Paul University, Chicago, IL
B.S., Chemistry, Loyola University, Chicago, IL
PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.
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Providing expertise in FDA management, investigation and compliance, medical device compliance inspection, drug manufacturing compliance investigation, biotech assessment auditing, forensic analysis, expert testimony, and related expertise to a wide variety of clients.
Speak to this experienced, world-class expert now.
- Call (317) 735-4628
- E-mail npc@rapid-response-consulting.com
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Senior Consultant
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Performed assessment audits of sterile drug manufacturers, biotech facilities and medical device manufacturers in the US, Europe and South America.
National Expert Investigator, Medical Device Group, ORA, Division of Emergencies and Investigational Operations (DEIO)
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Performed inspections of Medical Device products for compliance to QS-GMPs, PMAs, 510(k)s and other special requirements. Also performed drug inspections for compliance to GMPs, ANDAs and NDAs and other requirements. he served as the sterile medical device and process validation expert. using special training in sterilization processes, aided and assisted other national experts and FDA field investigators in these areas for biologics, drugs, medical devices and foods with guidance and director for the sterilization processes used in those product areas. Also conducted Pre-Operational reviews for new facilities and evaluated process validation packages.
Trained less experienced FDA investigators and personnel from foreign governments, state and local agencies. Assisted Compliance Officers in the development of effective legal actions and testified in legal proceedings before federal grand juries and at trial proceedings. Was often called upon to deliver speeches for EIO and Industry Association meetings and conferences.
Senior Drug Investigator, FDA Chicago District
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Received basic training in Food and Drug Law, investigational and inspectional techniques and sample collections. Conducted inspections and sample collections in all product areas regulated by FDA. After initial training, independently performed regulatory inspections at most of the registered drug and medical device manufacturing firms in the Chicago District and other FDA Districts as well as drug and medical device firms in foreign countries.
Trained less experienced FDA investigators and personnel from state and local agencies. Assisted Compliance Officers in the development of effective legal actions and testified in legal proceedings before Congressional Committees, and Federal Grand Jury proceedings. Was often called upon to deliver speeches for the Chicago District at FDA and Industry Association meetings. Prepared detailed reports (EIRs) of the inspected firm's compliance status with regard to the applicable GMPs and the firm's compliance to their processes and operating procedures as provided in written submissions to the FDA. Violations were documented by collecting evidence of the observed non-compliances.
Staff Chemist , DCASR, St. Louis, MO
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Was responsible for providing assistance and technical guidance to quality assurance personnel in the areas of drugs, chemicals, pharmaceuticals and medical devices. Performed pre-award surveys to evaluate supplier’s ability to manufacture products in compliance with government contract requirements, specifications and quality control and housekeeping standards. Performed technical audits or work performed by quality assurance representatives in the field offices. Developed procedures, plans and programs related to these product areas.
Quality Assurance Chemist, DCASR, Chicago, IL
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Performed all Dept. of Defense (DOD)/DSA quality assurance functions on government contracts for drugs, pharmaceuticals, dental and medical devices and subsistence items (including the NASA Space Food program) in the Chicago area. Provided training to all quality assurance personnel in Quality System requirements, MIL-STD 105 Sampling Plans, Calibration Standards and other applicable requirements. Assisted DOD Headquarters personnel in the performance of pre-award surveys to evaluate each supplier's ability to manufacture their products in compliance with government contract requirements, specifications, quality control and housekeeping standards.
Staff Chemist, INSMAT Chicago, IL
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Performed all Dept. of Navy quality assurance functions on Government contracts for drugs, pharmaceuticals, dental and medical devices and subsistence items in the Chicago area by personally observing the manufacture of the products and performing the inspections and testing of the products assigned to him. Received training in all quality assurance areas such Quality System requirements, Mil STD 105 Sampling Plans, Pharmaceutical Manufacturing Standards, Inspection Techniques for each product area, Calibration Standards and other applicable requirements.
Analytical Chemist, MST Chicago, IL
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Was an Analytical Chemist for the Military Subsistence Testing Laboratory (MSTL) under the Department of the Army (DA) in Chicago, IL, while completing B.Sc. Degree in Chemistry. Was in a Chemist Trainee Course conducted by the DA. During the years at MSTL, became a lead chemist in the laboratory performing tests on every subsistence item procured by the DOD for military subsistence. Each of those products is monographed in the AOAC.
HONORS AND AWARDS
Department of Health and Human Service, FDA Commissioner’s Award for Distinguished Career Service
Ronald H. Brown Award – For Technical Assistance to Israel
FDA Group Recognition Award, as a member of the Us/Israel Science and Technology Commission Group
Dept. of Justice – Commendation for Service as Case Agent in successful prosecution and conviction of a generic drug manufacturer
Department of Health and Human Service, FDA Commissioner’s Commendable Service Award for significant prosecution and conviction of a generic drug manufacturer
FDA Commendable Service Award – Chicago Drug Investigative Team
FDA Regional Director’s Recognition Award
Nominated as “Federal Employee of the Year
Monetary Awards for Sustained Superior Performance and Special Acts of Service, Chicago
PROFESSIONAL AFFILIATIONS
Association for the Advancement of Medical Instrumentation (AAMI)
Panel Member, FDA
Parental Drug Association – (PDA)
PUBLICATIONS
Presented numerous speeches, both foreign and domestic, on FDA enforcement and regulatory policy and inspectional procedures.
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