Insights On Regulatory Compliance

  1. Project Management: The Secret Weapon In Effective Tech Transfer 5/23/2024

    Explore how a CMO with innovative practices and a successful approach to tech transfer and manufacturing processes can help meet project timelines and mitigate risk on the path to market.

  2. Optimizing CAPA For FDA Recall Success: A Roadmap For Life Sciences Quality Professionals 12/27/2024

    Discover why an optimized CAPA process is crucial for life sciences companies to enhance quality, ensure regulatory compliance, prevent product recalls, and maintain market competitiveness.

  3. Unlocking The Potential Of Digital Transformation Tools In The Biopharmaceutical Industry 10/4/2024

    Why do many BioPharma organizations still struggle to gain the crucial benefits they desire from their data and digital transformation tools?

  4. Accelerate Production Through Digital Commissioning And Qualification 12/17/2024

    Watch to learn how digital validation streamlines commissioning and qualification (C&Q), improving productivity, compliance, and cost-efficiency across your organization.

  5. Navigating GxP Compliance Challenges 10/30/2024

    Learn how to select and manage trusted software suppliers to streamline your digital transformation, mitigate risks, and ensure regulatory adherence. Watch to discover best practices and real-world examples.

  6. Building An Effective Contamination Control Strategy For Final Sterile Filtration 8/13/2024

    Watch to learn about important considerations for final sterile filtration throughout product development and for performing pre-use post-sterilization integrity testing.

  7. Key Regulatory Considerations For The Next Wave Of Gene Therapies 2/21/2025

    The evolving field of viral vector production, driven by advances in gene and cell therapies, is facing increasing regulatory scrutiny and analytical demands.

  8. Guidance For Pass-Throughs In cGMP Cell And Gene Therapy Facilities 6/12/2023

    How do active purging pass-throughs offer a higher level of material control for cell and gene therapy facilities?

  9. Managing Risks In Injectable Drug Delivery 3/13/2025

    Gain insights pertinent to efficient and effective drug development. Understand and execute a risked-based critical thinking approach related to injectable drug packaging and delivery.

  10. The Hidden Costs Of FDA Recalls: A QMS Guide To Prevention 1/28/2025

    Did you know that FDA recalls have increased 115% since 2018? Learn more on how to avoid common recall mistakes and effective recovery strategies for your company today.