Insights On Regulatory Compliance

  1. Single-Use Strategies For Uninterrupted Microbial Monitoring 2/22/2024

    Watch as Emad Albarouki, a microbiology and sterility assurance specialist at Particle Measuring Systems, discusses the best practices for using BioCapt® Single-Use in continuous microbial active air monitoring.

  2. Maximizing ROI: Extracting Value From Analysis And Reporting 7/3/2024

    How can organizations establish the foundation for advanced analytics, AI and ML, in pursuit of a robust and adaptive lab of the future?

  3. Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections 12/20/2023

    Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

  4. SAP S4HANA Implementation: Commissioning, Qualification, And Validation 2/20/2024

    Explore how CAI helped one company navigate complications when implementing SAP and how new solutions are being developed, validated, and implemented to establish this new global ERP system.

  5. Biotech Files NDA Following Risk-Based Mock Inspection 6/14/2023

    See how the preventative approach an emerging biotech company took to mitigate risks and identify potential concerns before their FDA inspection and NDA submission ultimately led to success.

  6. Extending Quality Management Through Vendor Compliance Audits 5/25/2023

    Explore the primary responsibilities of both manufacturers and vendors during a vendor compliance audit, as well as practical strategies and tools, including audit management software, that make them possible.

  7. How To Avoid Warning Letters For Data Integrity Nonconformances In Life Sciences 11/10/2022

    Data integrity is established where the data is stored and managed in its original form. Discover why the FDA expects manufacturers to ensure all data meets the guidelines outlined in the ALCOA acronym.

  8. Integrated Annex 1 Compliance 6/5/2023

    Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.

  9. Robotics And Automation Addressing Production Shortages For Compounding Pharmacies 9/11/2024

    Drug shortages have increased the burden on compounding pharmacies. Robotics and automation can streamline processes, improve accuracy, and ensure quality to address challenges faced by these facilities.

  10. Time, Logistics, And Manufacturing In Autologous Cell Therapy Clinical Trials 5/12/2023

    Learn how the establishment of effective guidelines and standardization relevant to cell therapy development can help to minimize delays and lead to more positive outcomes.