ARTICLES BY IRWIN HIRSH
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![Compliance-GettyImages-1146618278]( "Improving Governance And Compliance With Knowledge Management")
Improving Governance And Compliance With Knowledge Management4/23/2024Knowledge management — it’s not just a soulless exercise. In the last part of his series, Hirsh helps bridge the gap between compliance and business needs.
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![Lightbulb-GettyImages-1404794851]( "How To Speed Up Time To Market With CMC Knowledge Management")
How To Speed Up Time To Market With CMC Knowledge Management1/24/2024Poor knowledge management delays regulatory approval and, thus, market access. Here's the first in a series examining the complexity of knowledge management for CMC and across the value stream.
Irwin Hirsh
Irwin Hirsh has nearly 30 years of pharma experience with a background in CMC encompassing discovery, development, manufacturing, quality systems, QRM, and process validation. In 2008, Irwin joined Novo Nordisk, focusing on quality roles and spearheading initiatives related to QRM and life cycle approaches to validation. Subsequently, he transitioned to the Merck (DE) Healthcare division, where he held director roles within the biosimilars and biopharma business units. In 2018, he became a consultant concentrating on enhancing business efficiency and effectiveness. His primary focus involves building process-oriented systems within CMC and quality departments along with implementing digital tools for knowledge management and sharing.