Director of Regulatory Affairs @ (January 2005 - January 2013)
Associate Director, Regulatory Affairs @ (September 2005 - February 2011)
Amy Tezel Education
UC Santa Barbara
Doctor of Philosophy (PhD) (Chemical Engineering)
1999-2005
University of Washington
BS (Chemical Engineering)
1995-1999
Amy Tezel Skills
21 CFR Part 11
Aseptic Processing
Biopharmaceuticals
Biotechnology
CAPA
Change Control
Class III Medical Devices
Clinical Development
Clinical Trials
Design Control
FDA
FDA GMP
GCP
GLP
GMP
GxP
IND
ISO 13485
ISO 14971
Leadership
Medical Devices
PMA
Pharmaceutical Industry
Quality Assurance
Quality System
Regulatory Affairs
Regulatory Requirements
Regulatory Strategy
Regulatory Submissions
Sop
Strategy
Technology Transfer
U.S. Food and Drug Administration (FDA)
V&V
Validation
eCTD
Change Management
Management
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Amy Tezel Summary
Amy Tezel, based in Summit, NJ, US, is currently a Senior Executive Scientific Strategist at 3D Communications, LLC. Amy Tezel brings experience from previous roles at BVI Medical, Alcon and 3D Communications, LLC. Amy Tezel holds a 1999 - 2005 Doctor of Philosophy (PhD) in Chemical Engineering @ UC Santa Barbara. With a robust skill set that includes 21 CFR Part 11, Aseptic Processing, Biopharmaceuticals, Biotechnology, CAPA and more. Amy Tezel has 2 emails and 2 mobile phone numbers on RocketReach.
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