Insights On Quality Control

31. Building Control Strategies: It's Time To Go Digital 1/24/2025

    Digital control strategies in pharma enhance product quality, regulatory compliance, and efficiency by leveraging real-time monitoring, automated documentation, and Quality by Design (QbD) frameworks.

32. Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance 6/6/2024

    Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.

33. 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.

34. Strategic CMC Planning Through A Phase-Appropriate Quality Approach 5/28/2024

    A phase-appropriate quality approach ensures quality activities align with the unique risks and challenges of each development stage. Watch to learn how to apply such an approach to chemistry, manufacturing, and controls planning.

35. Leachables Method Development, Validation And Relevant ICH References 5/16/2025

    It is crucial to develop and validate analytical methods capable of detecting a wide range of potential organic and inorganic leachables specific to the drug and its packaging.

36. 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.

37. 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.

38. Digitizing Quality Management: The Key To Avoiding FDA Recalls In Life Sciences 1/13/2025

    Explore the need for digital quality management systems to ensure compliance as life science companies face rising FDA recalls.

39. Seamlessly Integrating An E-WorkBook With A Customer's LIMS 8/12/2024

    Explore the story of a global biopharma company's integration of E-WorkBook with their LIMS, automating ADA study reports, saving significant time, and enhancing data accuracy.

40. Nitrosamine Impurities Deadline: Are Your Products Compliant? 12/5/2023

    Learn how to select an experienced nitrosamine mitigation provider and how a tailored, quantified strategy can help you bring your product into compliance while maintaining control of the process.