ARTICLES BY IRWIN HIRSH
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![radar, technology-GettyImages-2222711032]( "Building Enterprise Resilience From QRM Signals")
Building Enterprise Resilience From QRM Signals1/16/2026Turn 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.
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![businessmen working on laptop-GettyImages-1531692011]( "Metrics, Not Audits, Should Lead Vendor Accountability")
Metrics, Not Audits, Should Lead Vendor Accountability1/9/2026Episodic vendor audits are better suited for high-risk areas. An oversight system, based on a hierarchy of metrics, provides greater value.
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![pharmaceutical manufacturing-GettyImages-2230289877]( "Why Your MVP And Its Evolution Matters To Manufacturing")
Why Your MVP And Its Evolution Matters To Manufacturing12/8/2025Minimum 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.
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![GettyImages-1770654774-presentation-graph-computer]( "A Case Study In Continuous Process Verification")
A Case Study In Continuous Process Verification9/8/2025CPV can strengthen the bridge between compliance and continuous improvement. In this scenario, a hypothetical lab sets out to improve process yields and efficiency.
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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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![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.
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.