Background

Credentials

• B. S. Medical Technology
• M.S. Clinical Chemistry and Laboratory Management
• Registered Quality Assurance Professional – RQAP-GLP
• Registered Medical Technologist – American Society Clinical Pathologists and California Medical Technologist

Experience

• FDA Good Laboratory Practice (GLP) experience with a variety of pharmaceuticals, devices and combination products ranging from start-up to international companies  – since 1989
• Cardiac Device experience includes valves, stents, robitics, and interventional cardiology – since 1997
• FDA Good Manufacturing Practice (cGMP) – since 2000
• Quality Assurance, Quality Systems and Quality Control – over 20 years
• International Regulations including OECD, Japan, England, etc.
• Previous Director of Quality Assurance and Quality Control for a national veterinary testing facility performing FDA and EPA GLP studies. Responsible for development and implementation of all systems for compliance with FDA GLP regulations.
• 12 years human medicine – Administrator for Clinical Pathology, Histology, Nuclear Medicine, Respiratory Therapy and Cardiovascular Laboratories
• Designed and managed contract archive in compliance with FDA and EPA regulations
• Equipment and computerized system validation and qualification
• Data Auditing experience with Bioanalytics, Pharmacokinetics, Toxicokinetics, FACS Analysis, Device Engineering, Angiography, Echocardiography, Cardiac Data, Clinical Pathology, Histopathology and others
• 21 CFR Part 11 Project Management

• Systems Development

• Equipment validation

• Responsible for design and implementation of several quality systems for hospital laboratories in accordance with state, federal and JCHAO regulations

• Experience with a variety of software packages for data and statistical analysis.
      

Professional Affiliations

• Society for Quality Assurance

• Founding Member Medical Device Specialty Section, SQA

• SQA Regulatory Forum – Medical Device Liaison to the FDA

• Pacific Chapter of the Society for Quality Assurance - Secretary, Treasurer, and Board of Directors

• American Society for Quality

• Regulatory Affairs Professionals

• American Society for Clinical Pathologists
  

Publications

• Contributing Author International Quality Assurance Journal

• Poster Session 2001 SQA Meeting – GLPs for Medical Devices
    

Speaking Engagements

• SQA Annual Meeting April 2007 - Pre and Post conference training see www.sqa.org for details
    

This unique combination of experience and education in human medicine, hospital management and research for drugs, biologics, devices and combination products can benefit your company.

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