Articles by Irwin Hirsh

  1. Building Enterprise Resilience From QRM Signals 1/16/2026

    Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.

  2. Deploying A Vendor Life Cycle Oversight Model 1/9/2026

    A practical guide for adding oversight, based on a hierarchy of metrics, to quality agreements to transform them into living, metrics-driven control instruments.

  3. Metrics, Not Audits, Should Lead Vendor Accountability 1/9/2026

    Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.

  4. Why Your MVP And Its Evolution Matters To Manufacturing 12/8/2025

    Minimum viable product is one of the most important inputs to developing a manufacturing process. It defines essentials that matter to the people who make the product.

  5. The Promise And Paradox Of QbD 11/24/2025

    The difference between QbD as burden and QbD as advantage lies in critical thinking supported by structure — a hierarchy of metrics, toolsets, and tailored platforms.

  6. A Hierarchy Of Metrics Brings Strategy Into Biopharma's Daily Work 11/21/2025

    Information now flows faster than organizations can think about it, and without deliberate structure, decision-making becomes reactive rather than reflective.

  7. A Case Study In Continuous Process Verification 9/8/2025

    CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.

  8. 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.

  9. 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?

  10. 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.