Articles by Irwin Hirsh

  1. Lean Thinking For Pharma — Flow Without Facility Upheaval 4/28/2025

    Lean 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.

  2. Embracing An Economic Model For Agile Process Development 11/27/2024

    If AI-led discovery brings the surge in new candidates it promises, will process teams be ready?

  3. Team Topologies For Outsourced CMC Development 9/27/2024

    When functions such as analytics or formulation get outsourced, team dynamics must adapt to ensure cohesive integration and effective communication.

  4. Accelerate CMC Development With Team Topologies 9/20/2024

    A method of defining role boundaries for knowledge workers in the IT industry maps nicely to CMC process development for biologics and pharmaceutical manufacturing.

  5. Why Knowledge Workers Must Embrace Standard Work 7/10/2024

    Highly educated scientists often resist the notion of standard work because it seems stifling. On the contrary, standard work can increase productivity and creativity.

  6. Improving Governance And Compliance With Knowledge Management 4/23/2024

    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.

  7. Digitizing CMC Knowledge Management 4/8/2024

    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.

  8. Process Mapping For More Effective Knowledge Management 2/26/2024

    It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.

  9. How To Speed Up Time To Market With CMC Knowledge Management 1/24/2024

    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.