Insights On Regulatory Compliance

  1. Improving Bioprocess Monitoring And Control With Multivariate Data Analysis 12/9/2024

    Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.

  2. Demolishing Doubts About AI In Pharma 1/15/2025

    The FDA and PDA's recent initiatives provide frameworks and guidance for integrating AI into pharmaceutical manufacturing, emphasizing innovation, and safety.

  3. EU To U.S. Market: Understanding 3 Core Regulatory Contrasts 9/20/2024

    Learn about three key regulatory differences between the United States and the European Union that can significantly impact the success of your market entry.

  4. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  5. Could RFID-Based Unit-Level Traceability Be Key To Operational Excellence? 9/5/2023

    Radiofrequency identification (RFID)-based unit-level tracking solutions for prefilled syringes are poised to help pharma manufacturers address key risks and costly bottlenecks related to the fill-finish process.

  6. A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems 10/3/2024

    One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

  7. 5 Drug Manufacturing Trends To Look For In 2025 1/6/2025

    The life sciences industry faces big changes in 2025. Companies must adapt to new regulations, AI, and shifting manufacturing landscapes to stay competitive and drive innovation.

  8. The Role Of IV Bag Inspection In Drug Manufacturing 2/5/2025

    Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.

  9. The Ex-Regulator's View On Small Surface Contamination Control 2/26/2025

    Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. ​Learn about the critical steps, techniques, and validation needed to ensure product safety.

  10. Navigating Global Regulatory Landscapes In An Evolving Biopharma Industry 4/15/2025

    Minimize regulatory risks and ensure compliance in the evolving biopharma sector. Watch this on-demand discussion for insights on change management, supplier collaboration, and future market trends.