Course offering number:1203-304
Course ID:
1900
Design Control and Product Validation
12-13 March 2012
Amsterdam, The Netherlands
Jan Miller; Quality Systems Consultant, Vantage Consulting International, Ltd.
Jan Miller, a Quality Systems Consultant, has over twenty-five
years experience in the U.S. and International Healthcare
industry. She has directed responsibilities in Medical Device
Quality System Requirements (QSR), Design Control, Medical
Device Reporting, Recall and Field Corrective Actions, Good
Laboratory Practices, Premarket Notification (510k), European
Technical File, New Drug Applications, Investigational Device
Exemptions, and Quality Audits at various divisions of Baxter
Healthcare and Allegiance Healthcare. She assisted with the
implementation of cGMP/ISO quality systems for the first
company inside Russia to obtain ISO certification. Ms. Miller
has a B.A. in Business Management. She is Regulatory Affairs
Certified (RAPS) and is a Certified International Quality
Assurance Lead Assessor (IQA). She is a member of The
American Society of Quality (ASQ), and Regulatory Affairs
Professional Society (RAPS).
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