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Resume of QCI, Ph.D.
Consultant

EXPERTISE AND SERVICES

Biochemist, Scientist, FDA Regulatory Compliance Consultant, Risk Management Expert, R&D, Forensic Analysis, Accident Investigation, Accident Reconstruction, Expert Witness Testimony, Consulting Services
Expertise in biotechnology, healthcare industry, clinical trials, FDA GCP regulations, and R&D direction.

This KKAI Associate offers expertise specific to FDA-approved diagnostic kits, systems, first generation biotechnology reagents, FDA regulations for IVDs and pharmaceuticals, R&D expertise, risk management, risk assessment, design controls, management requirements, CAPA, training, test method validation, product-specific and common process validations.

Highly regarded in areas including risk and hazard analysis, FDA compliance regulations, diagnostic medicine, cancer research, immunoassay development, defense contracting, environmental test systems, strip test development, and product assessment.

Additional areas of specialty include GLP laboratories, GLP audits, pre-clinical pharmaceutical studies, training in diagnostic medicine, FDA regulations and risk assessment

PRINCIPAL INDUSTRIES SERVED
Biochemical, Medical, Molecular Biology, Pharmaceutical and Pharmaceutical Manufacturing

EDUCATION
Ph.D. Biochemistry, WVU Medical Center (NCI Pre-doctoral Fellow)
M.S. Biochemistry, WVU Medical Center
B.S. Pre-Medicine, West Virginia University
Amer. Cancer Soc. & NICHD Post-Doctoral Fellow, Oak Ridge Nat’l Lab.
AAMI Certification Course for GMP/QS Requirements & Industry Practice

PROFESSIONAL EXPERIENCE
Consultant, Kevin Kennedy & Associates, Inc.

Providing expertise in biochemical consulting, regulatory compliance consulting, risk management consulting, R&D expertise, forensic analysis and related expertise to a wide variety of clients.

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Case Studies

President, Educational Initiatives firm for Medical Laboratory, Diagnostic Testing, and Pharmaceutical Clinical Trials industries

President/Chief Scientific Officer, Scientific China Inc.

Director, Clinical Studies Institute, American Medical Laboratories

Director, Biotechnology Division, Hazleton Laboratories (Corning)

Director, R&D, MicroMedic Systems (Rohm & Haas)

Director, R&D, Quality Assurance, Miles Research Products Div. (Bayer)

Director, Tech. & Customer Service, Ames Company Div. Of Miles

ADDITIONAL EXPERIENCE

Provided consulting to Novartis (China Breast Cancer Study), Abbott Laboratories (FDA Compliance), Tetracore (Immunoassay Development), ARDAK (Defense Contractor), Environmental Test Systems (Strip Test Development), ATLIS (Government Contracts), American Association for the Advancement of Science (Speaker), Univ. of Miami (GLP),and Virginia Ctr Innovative Tech. (Biotechnology).
Helped develop QSR policies for clients in default of FDA regulations relative to Risk Management, Design Controls, Management Requirements, CAPA, Training, Test Method Validation, and both product-specific and common Process Validations.
Conducted and reviewed Product Assessments for over 100 products using a Risk and Hazard Analysis Approach.
Compliance remediation for products and processes out of FDA regulatory compliance
Established the first GLP laboratory in China. Conducted GLP audits for pre-clinical studies for pharmaceutical clients.
Established and conducted the first major clinical trial in China for a pivotal breast cancer drug obtaining early FDA approval.
Expanded government and pharmaceutical contracts doubling sales/profits for a contract research organization.
While staffing R&D, introduced design controls and a development system that generated 12 new diagnostic products in 2 years for a company that previously had not developed any new products for 3 years.
Conducted training throughout the world in various areas of diagnostic medicine, FDA regulations and risk assessment.

Please note that this is an abbreviated CV. A fully detailed unabridged CV is available under special circumstances.

Read articles by this associate:

FDA Quality System Requirements for Diagnostic Devices

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Case Studies

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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

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