ARTICLES BY IRWIN HIRSH
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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.