INSIGHTS ON REGULATORY COMPLIANCE

• Inside A Collaboration To Design Cutting Edge Modular Cleanrooms

  Learn about a collaboration that has yielded advanced modular cleanrooms, integrating cutting-edge building automation, critical monitoring, and data aggregation for manufacturing intelligence.

• Validation Of A Sterilization Process: Part 2

  Gain essential insights into sterilization processes by exploring the Overkill method—an approach that ensures product safety through rigorous cycle development and validation.

• The Future Of Biomanufacturing: Innovating Process Intensification Together

  Redefine your biomanufacturing by advancing process intensification technologies through strategic planning, innovation, and close customer collaboration to drive scalable and efficient solutions.

• Contamination In The Shadows: Risks Lurking From Environmental Issues

  Discover how science-based bio-decontamination strategies effectively eliminate invisible pathogens and rapidly restore facilities to operational safety following major infrastructure disruptions.

• Quality Roundtable: Raw Material Planning For Tech Transfer And Scaling Biologics

  1/22/2025

  Join this roundtable of biopharmaceutical professionals as they share their insights to help you navigate important quality and planning decisions for the progression of your biologic.

• Digital Transformation In Contract Manufacturing: A Leadership Perspective

  5/13/2025

  Discover how PCI Pharma Services embraced digital transformation and gain expert insight on overcoming challenges, driving innovation, and maintaining core values in a regulated industry.

• Translating Study Reports – A GLP Draft Guidance

  5/6/2024

  The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

• 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.

• How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows

  2/3/2025

  The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.