Regulatory

  1. Navigating Regulatory Shifts: EU GMP Annex 1 And USP 382 5/20/2025

    Strengthen risk mitigation strategies while ensuring regulatory alignment. Gain valuable insights into best practices and proactive approaches for building a robust and future-ready CCS.

  2. How To Evaluate The Integrity Of Intravenous (IV) Bags 7/7/2023

    Testing IV bags in compliance with Annex 1 guidelines requires a robust technology strategy to ensure product quality and patient safety. Learn how to deploy and validate technologies for IV bag CCI.

  3. A Practical Road Map For Compliance To EU GMP Annex 1

    Learn how to interpret the Annex 1 container closure requirements, develop deterministic analytical methods for CCIT, and design packaging studies that generate robust data demonstrating good CCI.

  4. Navigating Special Regulatory Pathways For Advanced Therapy Development Success 6/12/2025

    Don't let regulatory hurdles slow you down. Learn from leading experts about special designations like RMAT and PRIME to accelerate your advanced therapy development and ensure success.

  5. The Container Closure Integrity Requirements In The Revised EU Annex 1

    Learn about the advantages and disadvantages of CCI testing methods, how the revised EU Annex 1 may impact your strategy for ensuring CCI of sterile pharmaceutical products, and more.

  6. Your Contract Manufacturer Partner 12/14/2020

    Discover an integrated solution for pharmaceutical companies that offers a broad range of manufacturing services and capabilities to produce high-quality devices.

  7. Seal-Sensor Technology For In-Line Pouch Seal Inspection 11/16/2021

    PTI is integrating the latest technologies for inspecting pouch seals utilizing a method that inspects and analyzes pouch seals non-destructively. Seal-Scan and Seal-Sensor utilize Airborne Ultrasonic Technology (ABUS) that inspects and analyzes pouch seals non-destructively.

  8. The Pathway To Operational Readiness 6/24/2025

    Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

  9. Compressed Gas Risk Assessment: A Significant Step In Your CCS 10/10/2024

    Discover the importance of compressed gas monitoring in ensuring product quality and compliance with EU GMP standards.

  10. How Crucial Is Culture Media Selection In Environmental Monitoring? 6/20/2023

    Explore culture media regulatory requirements, the impact of manufacturing guidelines and media features and specifications on environmental monitoring, and the importance of media supplier selection.