Insights On Regulatory Compliance

  1. Extractables And Leachables: Setting Up Early For Success With Your CDMO 10/2/2024

    Discover insights tailored specifically for drug product researchers and manufacturers, offering key knowledge on extractables, leachables, and effective implementation strategies.

  2. Mitigating Nitrosamine Risks In Pharmaceuticals 6/25/2024

    Nitrosamines can come from a range of sources, including raw materials, manufacturing processes, and even water sources. Detecting them requires sensitive analytical methods.

  3. Contamination Control Strategy With QRM Principles 11/19/2024

    Contamination Control Strategies (CCS) have long been a main concept, but advancing requirements and regulatory expectations create a challenge. Learn how to be effective and compliant with your CCS.

  4. Sterile Filtration And Quality Risk Management 8/31/2023

    Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.

  5. Perspectives On Performance, Scalability, And Regulatory Compliance 10/28/2024

    Here, we discuss the challenges and solutions for cell and gene therapies, focusing on performance, scalability, and regulatory compliance to accelerate commercialization and improve patient access.

  6. Revolutionizing Drug Discovery: The Rise Of Fashionable Models 6/6/2024

    As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.

  7. The Problem With Construction Quality 10/21/2024

    Data center construction quality management is inadequate, with issues traced to human error. A stronger focus on quality control and assurance is needed for success.

  8. Leveraging Tech, Regulatory Frameworks To Deliver Patient Access Today 1/29/2024

    Amidst the shift toward decentralized manufacturing models, consider an approach that allows for standardized processes, remote monitoring and control, and centralized quality oversight.

  9. A Quality Management System For Ensuring Inspection Readiness 5/7/2024

    Marcel Inghilterra, PureTech's VP of IT, shares how Vault Quality can aid emerging biotech companies in accelerating the journey to inspection readiness across the drug development lifecycle.

  10. Why Should CDMOs Adhere To The New CDER's Rating System? 5/16/2024

    Delve into the benefits of the FDA's Quality Management Maturity (QMM) program, the rating system’s evaluation criteria, challenges, and steps to overcome these hurdles and achieve excellence.