Insights On Regulatory Compliance

  1. Computer Software Assurance: A Game-Changer For Life Sciences Compliance 9/18/2025

    CSA offers a smarter, risk-based approach to software validation that reduces documentation burdens while enhancing product quality. Learn how teams are using it to accelerate digital transformation.

  2. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

    Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

  3. Correlating Stopper Height To Container Closure Integrity 11/21/2023

    Learn how to comply with the new EU Annex 1 Section 8.28. Here, we describe a typical raised-stopper investigation and demonstrate how to generate scientifically robust data using headspace analysis.

  4. Revolutionizing Aseptic Fill/Finish With Innovation 4/21/2025

    Experience an innovative aseptic fill-finish technology designed for ATMP production in this live demo, which is a cutting-edge solution that ensures optimal efficiency and product quality.

  5. Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter 11/10/2025

    Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.

  6. Ensure Consistency Across Batches With A Powerful Tool 5/19/2025

    Learn how to streamline bioprocess control with an innovative software's Unit Save and Load feature. Save configurations, reduce setup time, and ensure consistency across batches with this powerful tool.

  7. Sample Sizes For Performance Testing Of Combination Products, Packaging 5/16/2025

    When developing combination products or evaluating primary packaging for drug products one must evaluate the performance of the devices and the packaging to ensure that they are fit-for-purpose.

  8. Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals 6/6/2024

    VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

  9. Cell And Gene Therapy Innovations 5/19/2025

    This interview with a pharmaceutical analytics expert discusses key insights into advances in cell and gene therapy and the strategies used to support customers in improving their therapeutic development.

  10. Achieving The Three Pillars In Life Science Manufacturing Validation 12/27/2024

    IQ, OQ, and PQ validations ensure equipment reliability, compliance, and quality in medical device and pharmaceutical manufacturing, meeting regulatory standards.