Insights On Regulatory Compliance

  1. Dry Powder Media Manufacturing Grand Island Expansion 11/5/2025

    Take a video tour of our newly expanded dry powder media manufacturing facility in Grand Island, New York. The expansion has added more than 45,000 square feet of Animal Origin Free (AOF) manufacturing space to help meet increasing global demand.

  2. 5 Ways GMP Manufacturers Can Start Improving Asset Performance Today 3/31/2026

    In GMP operations, poor asset control quickly becomes a compliance risk. Learn how maintenance and calibration gaps lead to deviations and why demonstrable asset performance is essential.

  3. Contamination Control Of Particulate And Shuttle Blow-Fill-Seal Compliance 2/24/2026

    Does shuttle blow-fill-seal truly meet Annex 1’s stricter contamination standards? New particle burden data challenges industry assumptions and reveals what manufacturers need to know.

  4. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  5. Implementing Rapid Microbial Identification In Biotherapy Manufacutring 5/27/2025

    Learn about rapid microbial identification strategies that enhance environmental monitoring and compliance with regulatory requirements for your manufacturing processes.

  6. Titer Analysis In The Era Of Complex Antibody Therapeutics 3/13/2026

    As antibody formats grow more complex, titer is harder to measure. Chromatography cuts through matrix noise to deliver accurate, scalable quantification from early development through QC.

  7. Alleviate Compliance Risks With Your EAM/CMMS 3/2/2026

    Discover how unified asset management enhances audit readiness by connecting maintenance, calibration, and quality insights, as well as how integrated workflows reduce compliance risk.

  8. Re-Engineering A Complex Process For FDA Compliance 8/21/2024

    Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

  9. Take Action Faster: Using The Alarm List In TSI FMS Web Client 8/4/2025

    Monitoring critical events and maintaining process compliance doesn't have to be a challenge. You can gain real-time visibility and control over your operations with a robust alarm management system.

  10. Achieve Pharma 4.0 With Next Generation Software-Defined Manufacturing 11/5/2025

    Explore how software-defined manufacturing is helping companies overcome legacy system challenges, improve OEE by up to 25%, and accelerate batch release cycles while maintaining compliance.