Deborah A. Miller, MS
Specialties: GLP, Regulatory
Biography
Deborah A. Miller, MS, is a Principal Consultant for Windshire. She holds a Master of Science, Laboratory Medicine from the University of Washington. Her background includes extensive experience in GMP, CLIA, ISO, Deviations/CAPA, Interdisciplinary Communications, Complaints, Quality Management System Development, Change Control, Quality Assurance Management, and Compliance Auditing.
Her Certifications include:
- Certified Manager of Quality/Organizational Excellence (ASQ) 2010 - 2014
- Certified Quality Auditor (ASQ) 2009 - 2013
- Certified Lead Auditor, ISO 13485, Medical Devices– Quality Management Systems – Requirements for regulatory purposes 2017
- Certified Lead Auditor, ISO 15189, “Medical laboratories – Particular requirements for quality and competence,” American Association for Laboratory Accreditation (A2LA)
- Certified Auditor, ANS/ISO/IEC 17025, General Requirements for the competence of testing and calibration laboratories, (A2LA)
Prior to joining Windshire Group, Ms. Miller was Director of Quality Assurance & Compliance, Diagnostic Manufacturing Division, American Red Cross and Special Assistant to the US Army Surgeon General Deputy Corps Chief for Laboratory Medicine.