Insights On Regulatory Compliance

  1. EU GMP Annex 1 – Navigating The Road To A Successful Annex 1 Inspection 7/17/2024

    The complexities of EU GMP Annex 1 inspections can be challenging. At an event hosted by NIBRT and Cencora PharmaLex, industry experts shared key insights and best practices for ensuring compliance.

  2. The Role Of PUPSIT In A Contamination Control Strategy 7/25/2023

    Here, we discuss the relationship between the CCS and PUPSIT, highlight the role of sterilizing grade filtration in the control strategy, and talk about how this can change throughout the product life cycle.

  3. Harmonizing Regulatory Guidelines For Assay Validation 7/24/2024

    Explore a detailed process for validating ligand-binding assays, particularly for Fcγ receptor binding analytes or other structural isoforms.

  4. How To Get Ready For 21 CFR Part 820/ISO 13485 Harmonization 9/20/2024

    Explore the key aspects of the harmonization between 21 CFR Part 820 and ISO13485 and guidance regarding how to ensure compliance with the new Quality Management System Regulation (QMSR) standards.

  5. Quality Without Compromise: GMP Annex 1 For Sterile Manufacturing 2/4/2025

    Annex 1 sets EU regulatory standards for sterile manufacturing, which emphasize contamination control, quality management, and risk prevention to enhance patient safety and regulatory compliance globally.

  6. 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.

  7. 5 Questions On Exploring Healthcare Decision-Maker Sentiments 4/14/2025

    Research presented at AMCP 2025 uses natural language processing on decision-maker feedback to predict coverage. Learn about the surprising findings and next steps in this Q&A.

  8. 5 Biggest Sterilization Challenges Facing Manufacturers 5/27/2025

    Sterility is non-negotiable in pharmaceutical and medical device manufacturing. Discover the top five sterilization challenges facing manufacturers today and the proven strategies to overcome them while ensuring compliance and safety.

  9. How To Prepare For An Inspection: 8 Tips For Success 3/15/2024

    To achieve a successful inspection, organizations should adopt best practices. Examine these eight invaluable tools for inspection success.

  10. Regulatory Considerations When Choosing Stem Cell Media 10/31/2024

    Watch to explore key considerations for researchers moving from academia to industry or expanding their operations.