Regulatory

  1. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing

    Experts on regulation, filtration, sampling, and quality control discuss risk assessment and filtration-based strategies to reduce bioburden.

  2. The Sensitivity Trap: Building Confidence In CCIT Performance 3/2/2026

    Effective CCIT goes beyond micron claims, focusing instead on repeatability, confidence, and real‑world relevance. Learn how to define a defensible LOD and understand what auditors truly prioritize.

  3. Ensuring Integrity: A Comprehensive Approach To CCI 1/8/2026

    Deterministic CCI testing ensures compliance in packaging. Learn how advanced methods like Vacuum Decay, HVLD, and Helium Leak Detection deliver results aligned with USP 1207 and global standards.

  4. Understanding The Regulatory Landscape For Ophthalmic Drug Products 5/14/2026

    Learn how evolving ophthalmic regulations, contamination control strategies, and advanced packaging solutions can help support compliance, product quality, and patient safety.

  5. Start Packaging Development Early 5/12/2026

    To avoid costly delays later in the product lifecycle, it is essential to plan for key variables early and select container closure systems with confidence from the outset.

  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. 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.

  8. Combination Products: Navigating Regulatory Strategy, Design Verification 5/19/2025

    Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

  9. Artificial Intelligence's Potential In Pharma Manufacturing 6/13/2025

    Explore how pharma companies can leverage Stevanato Group’s AI technologies while navigating FDA’s evolving, risk-based regulatory approach to disruptive innovations in this webinar.

  10. Importance Of Architectural Layout To Prevent Contamination 8/21/2025

    In this segment from the Pharmaceutical Online Live event, “Contamination Control Strategies For Drug Manufacturers,” panelists discuss the importance of unidirectional flow for preventing contamination, as well as specific architectural requirements related to the European Union's Annex 1 regulations. Poor or aging facility design is not an acceptable excuse for noncompliance.