INSIGHTS ON QUALITY ASSURANCE

• Getting CMC Right For Emerging Technologies

  Establishing a chemistry, manufacturing, and controls strategy that proves a clinical program is tightly controlled and can address risk is critical to avoiding the pitfalls that stall many promising therapeutics.

• Supply Chain Corrective Action Report Checklist

  Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.

• Direct And Rapid Multi-Attribute Monitoring Of Intact Monoclonal Antibodies By icIEF-UV/MS

  Explore a novel integrated workflow and system that offers direct chip-based integration of imaged capillary isoelectric focusing (icIEF) with mass spectrometry (MS).

• The Hidden Costs Of FDA Recalls: A QMS Guide To Prevention

  Did you know that FDA recalls have increased 115% since 2018? Learn more on how to avoid common recall mistakes and effective recovery strategies for your company today.

• Tailored ISO 5 RABs Unit To Protect AST's Patented Filling Machine

  6/19/2024

  Uncover how AST's satisfaction with Germfree's solution led to the acquisition of two additional units, showcasing the project's success and Germfree's expertise in tailored cleanroom solutions.

• Utilizing A Stepwise Approach For Nitrosamine Risk Mitigation

  5/15/2025

  Insights and case studies demonstrate how a tailored, stepwise testing approach can effectively detect, quantify, and control nitrosamine impurities while maintaining cost efficiency.

• Three Ways Manufacturing Excellence Drives Value For Life Sciences

  11/1/2023

  Check out three ways Honeywell’s Manufacturing Excellence Platform delivers value in terms of costs, revenue, and risk.

• Connecting Quality Management, Patient-Centricity, And Business Value

  2/18/2025

  Examine why organizations must integrate data and processes to enhance quality and insights to improve operational efficiency, patient health, and regulatory compliance.

• CAPA Management Improvement Process

  9/15/2023

  Gain insight into how a small team of experts worked to collect, trend, and understand the CAPA generation and completion process of a client struggling with on-time batch release, missed CAPA closure deadlines, and more.