Insights On Regulatory Compliance

1. Supply Chain Corrective Action Report Checklist 2/7/2025

   Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.

2. A Robust Extractables Data Package Helps Drive Patient Safety 10/1/2024

   Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.

3. A Mobile BSL-2 cGMP Cleanroom Delivered In Less Than 3 Weeks 6/6/2024

   A mobile cleanroom facility was needed for manufacturing a new monoclonal antibody product for phase 1 clinical trials. The facility had to have the ability to be repurposed for additional applications.

4. The Write Side Of AI: Augmenting Capabilities, Not Replacing Them 3/1/2024

   AI applications in medical writing are in their infancy, and the technology suffers several shortcomings including plagiarism, copyright infringement, and misinformation dissemination.

5. Realizing Business Benefit And Inspection Readiness With A Solid CAPA Framework 5/8/2024

   Embracing proactive quality culture transforms CAPA from a routine task to a continuous improvement tool. Learn how senior management support and robust processes drive excellence.

6. PUPSIT As Part Of A Contamination Control Strategy (CCS) 8/21/2024

   Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

7. Key Pillar Of A Successful CDMO: Exceptional Regulatory Compliance 10/18/2023

   Ensuring regulatory compliance is paramount for a CDMO to meet manufacturing standards, warrant patient safety, and maintain its reputation.

8. How CMOS/CDMOS Drive Industry Growth 4/16/2025

   From minimizing costs and accessing advanced tech to speeding market entry, dive into how outsourcing drug development and manufacturing to CMOs/CDMOs offers strategic advantages.

9. Navigating The Digital Frontier 5/15/2024

   This panel discussion looks ahead at decentralized manufacturing, key regulatory considerations, and the anticipated future where cybersecurity becomes a paramount focus.

10. Aseptic Expertise And Delivery Of Services 8/20/2024

    A pharmaceutical services company sought expert intervention after a routine requalification of their aseptic simulation process revealed a contaminated unit, halting commercial production for two months.