ARTICLES BY IRWIN HIRSH
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![Biotechnology, cell culture laboratory-GettyImages-1166528646]( "Lean Thinking For Pharma — Flow Without Facility Upheaval")
Lean Thinking For Pharma — Flow Without Facility Upheaval4/28/2025Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry.
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![Hirsh_Lifetime-Value_Feature_05]( "Embracing An Economic Model For Agile Process Development")
Embracing An Economic Model For Agile Process Development11/27/2024If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?
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![GettyImages-518177064_outsourcing]( "Team Topologies For Outsourced CMC Development")
Team Topologies For Outsourced CMC Development9/27/2024When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.
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![People-modern-technology-connection-GettyImages-1081165980]( "Accelerate CMC Development With Team Topologies")
Accelerate CMC Development With Team Topologies9/20/2024A 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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![female scientist petri dish syringe-GettyImages-1646509066]( "Why Knowledge Workers Must Embrace Standard Work")
Why Knowledge Workers Must Embrace Standard Work7/10/2024Highly 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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![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.