Insights On Regulatory Compliance

  1. FDA's Advanced Manufacturing Technology Program 5/6/2024

    Learn about a new Advanced Manufacturing Technologies (AMT) Designation program aimed at accelerating the implementation of technologies that drive speed to patient and enhanced sustainability.

  2. Navigating GxP Compliance Challenges 10/30/2024

    Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

  3. Streamline Early-Stage Development To Reach The Clinic Faster 7/17/2023

    Early-stage development is an iterative process, continuously generating new data and insights to optimize the product based on emerging knowledge.

  4. Closing The 'Knowing-Doing' Gap In R&D Using USP <1062> Data 7/24/2023

    Data acquisition system tools have come a long way and now you can learn which trial runs will help you generate the most valuable data.

  5. Advances In Regulations For Viable Environmental Monitoring 2/21/2025

    Viable air monitoring is critical for environmental monitoring programs in pharmaceutical manufacturing. Explore current regulatory standards as well as the impact of the EU GMP Annex 1 revisions.

  6. Early Network Mapping To Guide HTA Literature Reviews 3/18/2025

    How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.

  7. 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.

  8. A Guide To The Ultimate Product Improvement Tool 2/18/2025

    Learn how to transform your product quality review that emphasizes systematic evaluation and improvement of product quality, highlighting automation benefits through modern software.

  9. Navigating The Nuances Of Process And Analytical Development 5/15/2024

    This panel discussion explores the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice compliance.

  10. EU HTA – Achieving Broad Access Fast! What Will It Take For Innovative Medicines To Succeed? 3/18/2025

    Discover how to navigate the EU HTAR's Joint Clinical Assessment process. Learn from industry experts about accelerating patient access to innovative medicines in Europe.