Regulatory

  1. A Data-Driven Approach To Container Closure Integrity

    Gain confidence in your container closure system selection by utilizing a stepwise and data-driven approach to predicting and verifying container closure integrity.

  2. The Impact Of Water Activity Testing On Tablets And Capsules

    Watch to gain a comprehensive understanding of water activity testing as well as how to effectively use non-destructive headspace analysis to generate dependable water activity data.

  3. Attracting The Right Capital — Forming Partnerships For Long-Term Success 5/3/2021

    Experts share their experiences on investing in the cell and gene therapy field and how to form long-term partnerships for companies on the path towards bringing a potentially life-changing therapy to patients.

  4. 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.

  5. Selecting Container Closure Components: Extractables And Leachables

    Primary packaging components require a thorough assessment to ensure safety and efficacy. Plan ahead and start your assessment early to mitigate your risks, delays, and out-of-pocket costs.

  6. 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.

  7. Annex 1 FAQs: What Was The Biggest Challenge With EU GMP Annex 1? 5/11/2026

    Translating EU GMP Annex 1 into consistent site-level practice is where most manufacturers struggle. Hear why the global-to-local execution gap remains the industry's biggest compliance challenge and what it takes to close it.

  8. Annex 1 FAQs: How Is Behavior Changing As A Result Of EU GMP Annex 1? 5/11/2026

    EU GMP Annex 1 is driving meaningful changes in how teams behave inside cleanrooms. Understand what contamination awareness really means in practice and how to build a culture where speaking up is standard.

  9. Advanced CCIT Strategies For Combination Products 7/14/2026

    Gain insight into how deterministic CCIT methods support sterility assurance, product stability, and patient safety for prefilled syringes, auto-injectors, and other combination products.

  10. 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.