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FDA Quality System Requirements for Diagnostic Devices

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QCI is a Biochemist, Scientist, FDA Regulatory Compliance Consultant, Risk Management Expert with world-class expertise in biotechnology, healthcare industry, clinical trials, FDA GCP regulations, and R&D direction.

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This KKAI consultant worked with a major manufacturer of diagnostic devices to establish compliance to FDA regulations after that corporation had been issued a Consent Decree.  This involved conducting Risk/Hazard Analyses for over 200 products, review and reestablishing compliance for Management Control, Design Control, Test Method Validations, Process Validations, Corrective and Preventative Action Systems (CAPA), and Training.  During this project, this consultant led a group of consultants to work with the client to establish a new Common Process Validation approach adopted by the FDA   This was later presented by this consultant at the Regulatory Affairs Professional Society annual meeting in San Francisco.  This consultant also worked with another major manufacturer to transfer technology and manufacturing to Finland and to meet FDA regulations.  In 2006, this consultant worked with a university-based primate facility in preparation of a study to meet FDA preclinical regulations.
Biochemist, Scientist, FDA Regulatory Compliance Consultant, Risk Management Expert, biotechnology, healthcare industry, clinical trials, FDA GCP regulations, and R&D direction.
Resume of KJE electrical engineer, high voltage engineering expert, electrical power engineer, high voltage maintenance and safety training consultant, testing engineer, engineering failure analysis, accident investigation, accident reconstruction, specialist, forensic analysis investigation expert witness testimony, engineering consulting services
Resume of JHH bioscience manager, microbiologist, bio-technologist, scientist, product quality assurance consultant, specialist, forensic analysis investigation, expert witness testimony, consulting services
Resume of BYT biochemist, cgmp, glp, gcp, quality assurance, quality control consultant, regulatory compliance and validation consultant, forensic analysis investigation expert witness testimony, consulting services

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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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