Donna Hartzfeld

Donna Hartzfeld

Speaker
CONTRACTOR, REGULATORY SCIENCES – NDA Partners

Dr. Hartzfeld joined NDA Partners as an Expert Consultant in 2019. She is a quality assurance expert with more than 25 years of experience working in scientific research and FDA-regulated environments including pharmaceutical, medical device, IVD, biologics, and combination products. Dr. Hartzfeld has experience in all aspects of quality, laboratory, manufacturing, and regulatory requirements for FDA, MDR, IVDR compliance, including QA/QC Systems development and implementation, analytical laboratory and method controls, validation, document controls, warehouse and process controls, supplier/vendor management, design controls, auditing, training, and CAPA and complaint handling. She holds an auditor certificate for ISO 13485 medical device manufacturing standard. She is proficient at FDA inspection readiness planning and assisting in hosting PAI inspections. She has served the role as 3 rd expert in several FD-483/Warning Letter remediation projects. Also, she has performed many corporate trainings on Good Manufacturing Practices. She performs compliance due diligence audits for business acquistions in conjunction with law firms. Dr. Hartzfeld was formerly in Quality Assurance management in both the medical device and pharmaceutical industries. She started her career as a laboratory chemist in pharmaceutical drug development. She has served as a senior consultant with firms including the National Science Foundation Health Sciences Pharma Biotech Consulting, Quintiles Consulting, IQVIA, and Quality Implementation Services and several other consulting firms.
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