INSIGHTS ON REGULATORY COMPLIANCE

• Stories From The Field: Supporting Critical Steps In Fill And Finish

  Explore the critical final step in drug development—formulation and filling—and discover expert strategies that can help streamline operations, reduce risk, and enhance efficiency.

• Best Practices For Internal Quality Audits In Life Sciences

  Discover why internal quality audits are vital in the life sciences sector to ensure regulatory compliance, mitigate risks, and maintain high standards of product quality and patient safety amidst evolving challenges.

• Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing

  Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

• Reflecting Again On GMP Requirements For Marketing Authorization Holder

  Learn in detail about Annex 16, the responsibilities of Marketing Authorization Holders (MAHs), and a practical way for MAHs to implement their responsibilities with their contract manufacturers.

• DataOps For Manufacturing: A 4-Stage Maturity Model

  1/31/2024

  Explore a maturity model that was created to help you better understand where you are on your DataOps journey and where you need to go to achieve the results you expect.

• Mobilizing Compliance: USP 797 And 800 Pharmacy Trailer Fleet For VA Hospitals

  6/6/2024

  VA hospitals across the US are undergoing renovations to bring their facilities into compliance. The challenge was to design and manufacture a fleet of self-sufficient mobile compounding pharmacies.

• Optimizing Process Loads For VHP Decontamination

  2/20/2024

  Explore how CAI helped a company rescue a failing CQV project and create more efficient Vaporized Hydrogen Peroxide Material Air Lock (VHP MAL) Loads to enhance operational efficiency.

• Unlocking Audit Success: Navigate Compliance With Confidence

  12/17/2024

  Watch expert Kathianne Ross explore ALCOA+ principles, audit preparation strategies, and the role of digital validation in enhancing compliance and audit success.

• Time To Intensify: Taking mAb Manufacturing To The Next Level

  8/19/2025

  Explore how process intensification can revolutionize monoclonal antibody manufacturing to boost productivity, cut costs, and enhance sustainability with scalable strategies and real-world results.