Insights On Regulatory Compliance

  1. Innovations, Solutions, And USP <1062> With Scale Up 11/4/2025

    Optimize tablet compression by simplifying calibration, speeding up changeovers, and utilizing advanced laser inspection to prevent critical punch tip wear and maintain quality.

  2. What Do You Need To Do To Qualify A Single-Use Assembly? 8/28/2024

    Learn about the implementation of single-use technologies, single-use user requirement specifications, and best practices for single-use qualification, including quality and regulatory documentation.

  3. Chromatography In Biologics Manufacturing: Purification Science, Resin Applications, And System Qualification 11/24/2025

    Explore chromatography fundamentals, resin selection strategies, and the regulatory frameworks required to qualify automated systems for compliant, commercial-scale biologics manufacturing.

  4. Modified Release Formulations: Extending Drug Commercial Lifecycle 3/1/2024

    A CDMO with expertise in modified-release dosage forms can provide valuable assistance in formulation development, processing considerations, analytical challenges, and regulatory requirements.

  5. Development Of An Effective LC-MS/MS Cleaning Validation Method 7/17/2025

    Gain insight into a robust LC-MS/MS method for quantifying therapeutic peptides that supports contamination control and cleaning validation to ensure product safety and integrity.

  6. Safeguarding Quality In Parenteral Drug Manufacturing 10/16/2025

    Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

  7. Analytical Approaches For Quantifying Residual Host Cell DNA 5/29/2025

    In this webinar, we’ll discuss the challenges, risks and considerations involved in developing and using in-house residual testing solutions, and the benefits of using commercial kits for residual DNA testing.

  8. Uncovering Blind Spots In Environmental Monitoring 6/19/2025

    Discover how modern strategies like the Contamination Control Strategy are transforming environmental monitoring by exposing hidden risks, enhancing data quality, and unlocking deeper insights through innovative microbial methods.

  9. Zero To Final Fill: How HUGEL Implemented Its First Single-Use Lines 8/6/2025

    As regulations tighten, biomanufacturers are adopting single-use tech to boost compliance, reduce labor, and streamline fill-finish operations from the ground up.

  10. Understanding ISO/TR 14644-21 Airborne Particle Sampling Techniques 2/26/2025

    Industry expert Mark Hallworth guides viewers through the latest ISO document (ISO 14644), exploring the reasons behind the decisions made by the team during its development.