SKILLS/SPECIAL QUALIFICATIONS:
Nine years consulting experience in the fields of Laboratory Improvement, Laboratory assay validation, Clinical Laboratory Improvement Amendment (CLIA) and College of American Pathologists (CAP) accreditation, Laboratory Quality Control methods development and evaluation, premarket submissions, Quality Systems and Good Laboratory Practice (GLP) audits, quality documents development, clinical and environmental microbiology, laboratory planning and design consulting, and value engineering.
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Twelve years industry experience in managing development of in-vitro diagnostic devices.
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Fifteen years management experience in Clinical Laboratories and Clinical Laboratory Education. Languages: English.
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Twenty plus years expertise in 510(k) and PMA submissions
WORK EXPERIENCE:
1998- Present ATS LTD AFFILIATE
Consult for and assist international and domestic clients in the fields of medical devices, in-vitro diagnostics and biopharmaceuticals to develop quality assurance and regulatory strategies for compliance with FDA regulations by:
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Performing audits of medical device manufacturing companies in the areas of Quality Systems, Laboratory compliance and Good Laboratory Practices, Good Manufacturing Practices and general safety.
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Developing standard operating procedures (SOPs) and validation protocols for clinical laboratory assays used in clinical trial settings resulting in laboratory compliance with GLPs.
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Developing protocols for validation of commercial in-vitro diagnostic products to comply with CLSI and ICH standards.
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Developing 510(k) submissions for medical devices. Develop software 510(k) submission checklists and FDA submission criteria.
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Assisting in-vitro diagnostics companies in improvement to and corrective actions for the Quality System in response to FDA 483 Observations and Consent Decrees.
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Developing manufacturing and Quality Control procedures for suppliers of microbiology-related products and services to bring companies into compliance to GMPs and the FDA Quality Systems Regulation.
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Assisting US and international clinical laboratories to achieve CLIA and/or CAP accreditation.
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Consulting in process validation of Microplate and Lateral-Flow enzyme immunoassay manufacturing and for Biopharmaceutical development, processing and evaluation.
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Providing Value Engineering assistance to architectural companies in the field of laboratory design and compliance.
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Conducting assessments of client studies, procedures and programs to determine compliance.
1992-1998 Ostex International, Inc., Seattle, WA
Manager, Product Development
Management, design and development of diagnostic assays for clinical and research laboratories. Function as document control principal for R & D. Aid in creating, editing and reviewing Manufacturing Batch Documents.
Transfer products to manufacturing, and troubleshoot scale-up issues. Develop Quality Control procedures for new products.
Train Product Support and Technical Service Departments on new products. Manage Research Testing Service in a CLIA-certified Clinical Laboratory. Work with collaborating companies interested in Ostex technology.
TRAINING AND CERTIFICATION:
ISO Lead Auditor
1999 36 Hour ANSI/RAB Accredited Lead Auditor Course for ISO-9001 and ISO 13485.
Medical Technologist
1971 Registered Medical Technologist, American Society of Clinical Pathologists.
PROFESSIONAL AFFILIATIONS:
Regulatory Affairs Professional Society, 2001
Organization of Regulatory and Clinical Associates, 1989
American Association of Clinical Chemists, 1997
American Society for Microbiology, 1977
Medical Technologist, American Society of Clinical Pathologists, 1971
PUBLICATIONS:
2007 Handbook to Laboratory Best Practices, Training and Facing Challenges. C. Green, J. Cwiertniewics, J. Morgan, R. Berninger, J. Lanese and R. Marcus. Institute of Validation Technology, Duluth, MN. 2006 J Hix, P Rasca, J Morgan, S Denna, D Panagides, M Tam and AH Shankar.
Validation of a rapidenzyme immunoassay for the quantitation of retinol-binding protein to assess vitamin A status within populations. European Journal of Clinical Nutrition (2006), 1–5.
2004 Hix J, Shankar A, Dary O, Martinez C, Buchanan I, Morgan J, Tam M. Development of a rapid immunoassay for the detection of retinol binding protein (RBP-EIA). American Journal of Clinical Nutrition 2004;79:93-8.
1998 Measuring Response to Alendronate Therapy in Elderly Women by Serum Cross-Linked N- Telopeptides (NTX) Immunoassay. Poster Session, American Society for Bone and Mineral Research.
1997 Microplate ELISA for Measurement of Cross-Linked N-Telopeptides of Bone Collagen (NTx) in Human Serum. American Association of Clinical Chemists Poster Presentation.
1995 Microplate ELISA for Measurement of Cross-Linked N-Telopeptides (NTx) in Human Serum. Poster Session, American Society for Bone and Mineral Research.
1992 Synthetic Peptide-Based Immunoassay for the Detection of Antibodies to Hepatitis C Virus. American Society for Microbiology Annual Meeting.
1992 Synthetic Peptide-Based Immunoassay for the Detection of Antibodies to Human T-Lymphotropic Virus Types I and II. American Society for Microbiology Annual Meeting. 1988 Serological Diagnosis of Human Immunodeficiency Virus Infection by Western Blot Testing.
1988. Journal of the American Medical Association 260:674-679.
1987 Evaluation of a Rapid Method for the Determination of l-Pyrrolidonyl-β-Napthylamide Hydrolysis. Laboratory Medicine 18:682-683.
1986 Acquired Immunodeficiency Syndrome: Preventive Education and Infection Control Guidelines for Laboratory Workers. Southern Illinois University Correspondence Course. Hospital and Physicians Consulting Service.
1986 Rapid Determination of PYR Hydrolysis. Abstract C-115. Annual Meeting of the American Society for Microbiology, 1986.
1985 Comparison of Minimum Inhibitory Concentrations of Cefamandole, Cefazolin, Cephalothin and Vancomycin in Nafcillin-Resistant and Nafcillin-Susceptible
Stapylococci. Abstract C-107. Annual Meeting of the American Society for Microbiology, 1985.
1984 Calibration of Microbiological Loops by Flame Photometry. Laboratory Medicine 15:677-678.
1984 Correlation of Penicillin and Ampicillin Minimum Inhibitory Concentrations and Staphylococcus saprophyticus beta- lactamase production. Abstract A-37. Annual Meeting of the American Society for Microbiology, 1984.
1983 Abbreviated Scheme for Presumptive Identification of Staphylococcus saprophyticus from Urine Cultures.
1983. Journal of Clinical Microbiology. 18:1272-1274.
EDUCATION:
1971 B. Sc. Medical Technology, Pacific Lutheran Univ., Tacoma WA
1970 B. A. Biology, Pacific Lutheran Univ., Tacoma WA