Donna Hartzfeld, Ph.D.
Education
Arizona State University
Ph.D., Chemistry 1989-01-01 - 1995-01-01
University of North Carolina at Greensboro
BA, Chemistry and Biology 1983-01-01 - 1988-01-01Work Experience
Quality Implementation Services, Inc.
Current
Quality Implementation Services, Inc.
NDA Partners, a ProPharma Company
Current
NDA Partners, a ProPharma Company
IQVIA
Current
IQVIA
LumiraDx
2020-07-01 - 2022-08-01
LumiraDx
The FDA Group
2021-11-01 - 2021-11-01
The FDA Group
Natus Medical Incorporated
2019-04-01 - 2020-08-01
Natus Medical Incorporated
NSF
2014-05-01 - 2020-01-01
NSF
MedPlast Inc.
2013-01-01 - 2018-03-01
MedPlast Inc.
Bard Access Systems
2014-01-01 - 2017-01-01
Bard Access Systems
Lutonix, Inc.
2013-02-01 - 2014-05-01
Lutonix, Inc.
Skills
Summary
•Consultant with broad experience in all aspects of quality, laboratory, manufacturing and regulatory requirements for FDA compliance. Direct experience within 820, 210/211, ISO 13485, and ICH Q7A for APIs, Rx and OTC drug products in liquids, tablets, sterile products, combo, Class I, II, III devices. Have worked in early-stage startups, new products through international large corporation projects. Specialties: •Quality Systems Development & Upgrade •Analytical/Laboratory Controls •QSR, Q7A, 211 cGMP compliance •Lab Investigations •CMC Support •Quality Assurance •Audits-Internal/External •FDA Pre-Approval (PAI) Readiness Support •FD-483s and Warning Letters Remediation Support •Validation Support -Analytical, Equipment, Process, Facilities •Technical and SOP Writing •Customized Training Programs •Design Controls •Complaint and MDR Handling •CAPA investigations
