Insights On Quality Control

  1. ICH Q9 Revision 1: Enhancing Quality Risk Management 8/12/2024

    ICH Q9 Revision 1 advances the framework of Quality Risk Management (QRM) in the pharmaceutical industry, by addressing technological advancements and evolving regulatory expectations.

  2. Learn, Confirm, Then Scale: A Leader's Guide To Transforming QC 1/21/2026

    Legacy lab systems hinder innovation and scalability. Explore a proven approach to modernize QC through cloud-based LIMS, starting with small pilots that validate strategy and reduce risk.

  3. Inline Checkweighing Of Packaged Products In Manufacturing 12/29/2025

    Accurate inline checkweighing is vital for quality control. Learn how system design, software, and regulatory compliance work together to overcome high-speed production challenges.

  4. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  5. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

  6. Development To Large-Scale cGMP Production 7/25/2024

    For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

  7. Digitalizing Pharma Control Strategies: A Roadmap 1/24/2025

    Digitalizing control strategies in pharmaceutical manufacturing enhances product quality, compliance, and efficiency, leveraging data-driven approaches like QbD, and digital CPV for optimized processes.

  8. Inside The Cleanroom: Training Beyond The Checkbox 2/12/2026

    Effective cleanroom management requires moving beyond checkbox compliance. Learn how to empower your workforce by connecting individual roles to broader contamination control goals and behaviors.

  9. Detection Of Food Spoilage Organisms 3/5/2026

    Membrane filtration offers a faster, more precise approach to detecting spoilage organisms. See how its flexibility and accuracy make it a valuable tool for improving food microbiology processes.

  10. Understanding cGMPs For Phase 1 Investigational Drugs 8/15/2025

    Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.