Insights On Regulatory Compliance

  1. Future-Proofing Life Sciences Manufacturing: 2025 CDMO Trends 3/12/2025

    Review contract manufacturing's evolution, driven by technological advancements and regulatory changes, and how CMOs and CDMOs are navigating opportunities and challenges.

  2. Five Steps To Implementing CSA 12/17/2024

    Explore how the FDA’s CSA guidance simplifies computerized systems validation by emphasizing risk-based approaches, reducing documentation burdens, accelerating testing, and enhancing compliance.

  3. Compliance Audits: 4 Solutions To Avoid Failure 9/20/2024

    Although inspection and audit processes have evolved, you can still effectively navigate and manage them within your organization. Explore four solutions to address audit and inspection pain points.

  4. Overview Of Biological Indicator And Sterilization Monitoring Systems 7/2/2024

    Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.

  5. When Should Filter Validation Be Performed? 8/21/2024

    Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.

  6. The Problems With Construction Quality In Life Sciences 11/7/2023

    In the mission-critical construction industry, quality management is underperforming. Understand the importance of quality control in life sciences commissioning processes and construction programs.

  7. 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.

  8. Navigating The Launch Of ATMPs In Europe 5/29/2024

    In 2025, EU's Health Technology Assessment will reshape market access for ATMPs. Proactive planning is crucial for developers to navigate these changes and ensure patient access to innovative therapies.

  9. Nitrosamines - New Requirements To Evaluate Contamination Risks 12/23/2024

    Explore nitrosamine contamination, regulatory actions, and new evaluation requirements, featuring expert insights from Dr. Ulrich Reichert on prevention and risk assessment strategies.

  10. Regulatory Submission Crisis Rescue: When To Take Action 6/12/2023

    While a few red flags are common during any submission, several occurring in concert can precipitate a submission crisis. Learn how these can be avoided in this article.