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.
ARTICLES BY IRWIN HIRSH
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Embracing An Economic Model For Agile Process Development11/27/2024
If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?
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Team Topologies For Outsourced CMC Development9/27/2024
When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.
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Accelerate CMC Development With Team Topologies9/20/2024
A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.
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Why Knowledge Workers Must Embrace Standard Work7/10/2024
Highly educated scientists often resist the notion of standard work because it seems stifling. On the contrary, standard work can increase productivity and creativity.
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Improving Governance And Compliance With Knowledge Management4/23/2024
Knowledge 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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Digitizing CMC Knowledge Management4/8/2024
Systems that enhance know-how retention stretch from utterly simple to enterprise-scale. Here are some ideas for incorporating them into your knowledge management strategy.
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Process Mapping For More Effective Knowledge Management2/26/2024
It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.
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How To Speed Up Time To Market With CMC Knowledge Management1/24/2024
Poor 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.