Independent Researcher, United States
Sushant Kulkarni is a Senior Manager, QA Operations, at clinical stage biotechnology company and is specializing in GMP compliance, deviation investigations, and supplier quality systems. He has reviewed manuscripts for Molecular Therapy and ASQ’s Quality Progress, and serves on the 2026 National Biotechnology Conference Abstract Screening Committee. Sushant’s work focuses on risk based qualification, inspection readiness, and data driven CAPA effectiveness. He has led cross functional quality initiatives that streamline decision making and strengthen compliance without adding complexity. He presents in a personal capacity; views are his own.
Poster Presentation (In-Person)
Title: Data Integrity in Gmp Environments: Implementing Alcoa+ for Reliable, Defensible Quality Decisions
Poster Presentation (In-Person)
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