MAUREEN N. GARNER, MS, MT (ASCP), ASQ CQA, President

Maureen has over 27 years of industry experience in medical device, in-vitro diagnostics, and pharmaceutical firms, specializing in product approvals for diagnostics and devices, with an emphasis on point-of-care and over-the-counter diagnostics. After beginning her career as a hospital medical technologist, Maureen joined the medical device industry in 1981. She headed quality control and technical services departments, and over the following 22 years, she assumed increasingly responsible management positions in QA and regulatory affairs. Maureen was the Director of Regulatory Affairs at a major pharmaceutical company prior to founding NWRS. Ms. Garner possesses expertise in the preparation and submission of IDEs, PMAs, and 510(k)s for medical devices, as well as in clinical trial monitoring and clinical and GMP audits.

Maureen holds a BS degree in Medical Technology from Fairleigh Dickinson University, a Masters of Science degree in Pharmaceutical Regulatory Affairs from the School of Pharmacy at Temple University, and she maintains her ASCP certification. Maureen's commitment to quality and continuing professional education was recognized in June 2005, when she achieved Certified Quality Auditor status from the American Society for Quality (ASQ CQA).

GLENN NEUMAN, MS, Director of Scientific Affairs

After receiving his MS in Biochemistry from the University of Maine, Glenn's career began in basic medical research at Massachusetts General Hospital and progressed to discovery research at a major pharmaceutical company. The assay development skills he developed in research found widespread commercial application in the diagnostics industry. The natural progression of Glenn's assay commercialization efforts led him into regulatory affairs, technology transfer, manufacturing and quality systems management. Glenn has held scientific positions of increasing responsibility, and was Director of Technical Affairs at a major diagnostics company prior to joining NWRS. His over 30 years of experience enable Glenn to provide expert professional services including clinical and non-clinical protocol development, data management, quality systems requirements, clinical and GMP audits; and technical file preparation to support ISO certification and CE marking.

SUZAN FENICHEL, BS, MT (ASCP), Manager, Regulatory/Clinical

Suzan has over 37 years of experience in the clinical laboratory and diagnostic industry. She began her career as a Medical Technologist working in reference and hospital laboratories, managing physician office laboratories and worked as a researcher at a major instrument manufacturer. Suzan has assumed increasingly responsible management positions in Technical Services, Training, and Technical Support. Her expertise extends to product trend and customer complaint analyses, and Medical Device Reporting to the FDA, as well as to clinical trials management for Phase 1 drug studies including study planning and study conduct, and in the preparation of clinical trial study reports in support of 510(k) and NDA submissions.

Suzan holds a BS in Medical Technology from Fairleigh Dickinson University and has been a registered Medical Technologist for 37 years.

KATRINA FIELDER, BS, ASQ CQA, RAC-US, Director, Quality Systems/Compliance

Katrina has over 20 years experience in the medical device in vitro diagnostic industry specializing in the areas of Quality Systems, Global Regulatory Compliance, Technical Support, Training, and International Registrations/Licensing/CE Marking. During that time, she has assumed increasingly responsible management positions in those areas. Katrina Ôs approach to compliance is practical, strategic, cost-effective and hands-on. She has expertise in designing customer-tailored quality systems/reworking failing ones, developing a world-class technical support team, post market surveillance, recalls, medical device/vigilance reporting, ISO certifications, CE marking, international medical device registrations/licensing, and auditing (internal and supplier).

Katrina holds a BS Natural Sciences/Mathematics from Thomas Edison State College. She is committed to quality and continued professional education. Katrina is Regulatory Affairs Professional Society (RAPS) RAC-US certified and is an American Society for Quality (ASQ) Certified Quality Auditor (CQA).