Insights On Regulatory Compliance

  1. ICH Q12 Implementation: Regulatory Intelligence And PACM Agility 7/9/2024

    Here, we outline a practical framework designed to assist companies in implementing ICH Q12 from day one, enabling them to realize its benefits early on and paving the way for continuous improvement.

  2. Getting The CAPA Framework Right The First Time 5/8/2024

    CAPA processes, though often seen as regulatory burdens, offer significant business benefits. Implementing them requires a cultural shift and methodical approach for lasting improvement.

  3. Key Cleanroom Design Considerations For Drug Manufacturing 4/18/2023

    Compare and contrast the pros and cons of several cleanroom design and construction methods to determine the most suitable approach for your specific project.

  4. Bioburden And EU GMP Annex 1: Risk Assessment, Reduction, And Testing 3/10/2023

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

  5. Expert Approaches To Pharmaceutical Containment Design And Facility Integration 4/18/2023

    Review the process requirements, workflows, and process interventions that are key to your containment isolators achieving compliance with both cGMP and BSL-3.

  6. 21 CFR Part 11: 7 Ways To Avoid Noncompliance 12/20/2022

    Explore the elements critical to 21 CFR Part 11 compliance, how they relate to noncompliance risks, and how a QMS software solution for life sciences simplifies the compliance process.

  7. Deviation And Change Control In Pharmaceutical Manufacturing 9/20/2024

    Explore deviation management and change control in the pharmaceutical industry, the elements of Corrective and Preventive Action (CAPA), and how to best approach these three interconnected processes.

  8. 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.

  9. Advancements In Ophthalmic Drug Manufacturing: Precision And Scale 7/31/2024

    Learn how a CDMO partner that leverages a multidisciplinary team approach can help you achieve effective scale-up production, handle potent compounds, and ensure regulatory compliance.

  10. How To Easily And Quickly Monitor Cleanrooms 5/6/2024

    Discover a portable particle counter for quick and easy cleanroom monitoring that features automated alarms and reporting to help you ensure compliance.