Insights On Quality Control

  1. Software Simplifies 21 CFR Part 11 and Annex 11 Compliance 12/9/2024

    21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.

  2. Next-Gen Medium And Feeds System To Improve CHO Cell Line Productivity 6/19/2024

    Choose the right CHO medium and feed system to optimize your upstream processes and secure a seamless scaling up.

  3. Essential Insights Into Pharmaceutical Product Release, Part 1 Of 2 12/27/2024

    Pharma product release ensures drug quality, safety, and regulatory compliance by evaluating manufacturing and quality processes. It’s a critical, comprehensive process essential for FDA approval and patient safety.

  4. Common Tablet Defects And The Importance Of Blending 2/21/2025

    Learn to minimize tablet defects like picking, sticking, and capping. This webinar explores common issues and the critical role of blending in achieving quality tablets.

  5. CMO Validation As A Service 8/20/2024

    Learn about the highly successful commissioning and qualification of Wheeler's Oklahoma City CDMO facility with the overarching goal of ensuring all equipment was qualified for a Phase 3 clinical production campaign.

  6. 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.

  7. Understanding The Hidden Value Of Quality 6/26/2023

    Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.

  8. Nitrosamine Impurities Deadline: Are Your Products Compliant? 11/6/2023

    The FDA nitrosamine contamination guidance set a deadline of August 1, 2025, for all drug manufacturers and market authorization holders to comply fully with the NDSRI limits set.

  9. Development To Large-Scale cGMP Production 7/25/2024

    For manufacturers working with a dry powder medium (DPM), early consultation with a supplier can increase the likelihood of success. Uncover a two-phase scale-up strategy for the production of DPM.

  10. Monitoring Microbial Contamination Of Mammalian Cell Cultures 2/21/2025

    Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.