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Michael Gatta Location
Boston, MA, US
Michael Gatta Work
2026 -now President and Owner and Senior Project Manager @
2024 -2025 Vice President of Services @
2022 -2023 Vice President of CQV @
2011 -2022 Principal @
2013 -2018 Validation Consultant @ Shire
2011 -2013 Principal @ Genzyme
2010 -2011 Validation Manager @ Ipsen
2000 -2010 Northeast Operations Manager @
2003 -2010 Project Manager @ AstraZeneca
Michael Gatta Education
Worcester Polytechnic Institute
Bachelor of Science - BS (Biology)
Michael Gatta Skills
21 CFR Part 11
Change Control
Validation
Computer System Validation
GMP
CAPA
ISO 13485
Biopharmaceuticals
Aseptic Processing
Regulatory Submissions
LIMS
FDA
V&V
Sop
Pharmaceutical Industry
GCP
Medical Devices
Biotechnology
Quality System
GxP
Regulatory Affairs
Cleaning Validation
Quality Auditing
Regulatory Requirements
Process Simulation
Clinical Trials
Technology Transfer
Quality Assurance
GAMP
Pharmaceutics
Lifesciences
Software Documentation
HPLC
GLP
Trackwise
Vaccines
Quality Control
Drug Development
Life Sciences
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
U.S. Title 21 CFR Part 11 Regulation
Verification and Validation (V&V)
High-Performance Liquid Chromatography (HPLC)
Standard Operating Procedure (SOP)
Verification And Validation V&V
High Performance Liquid Chromatography Hplc
Corrective And Preventive Action Capa
Operations Management
U.S. Food And Drug Administration Fda
Management
Standard Operating Procedure Sop
Integration
Corrective and Preventive Action
u.s. Food and Drug Administration
Standard Operating Procedure
Verification and Validation
High Performance Liquid Chromatography
Michael Gatta Summary
Michael Gatta, based in Boston, MA, US, is currently a President and Owner and Senior Project Manager at Paladin Bio Consulting, LLC. Michael Gatta brings experience from previous roles at Ellab - Validation & Monitoring Solutions, ICQ Consultants (Integrated Commissioning & Qualification Corp.) and Shire. Michael Gatta holds a Bachelor of Science - BS in Biology @ Worcester Polytechnic Institute. With a robust skill set that includes 21 CFR Part 11, Change Control, Validation, Computer System Validation, GMP and more. Michael Gatta has 1 emails and 3 mobile phone numbers on RocketReach.
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