ARTICLES BY IRWIN HIRSH
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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.