Regulatory

  1. Simplifying Bioprocess Data Collection 2/17/2023

    Centralized bioprocess data collection and aggregation lowers the risk of data loss during any manual retrieval process. Discover a solution that helps you meet data storage and reporting requirements.

  2. 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.

  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. Key Considerations When Developing Your Combination Product 2/20/2024

    Succeed in combination product development by understanding the risk factors that may arise and implementing mitigation strategies that will streamline the device development process.

  5. 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.

  6. 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.

  7. 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.

  8. Human Factors Testing: Engaging End-Users In Med Device Development 3/11/2025

    Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

  9. 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.

  10. Nitrosamine Impurities Deadline: Are Your Products Compliant? 12/5/2023

    Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.