Insights On Regulatory Compliance

31. Balancing Customization And Standardization With Targeted Medicines 8/30/2024

    Examine an overview of the challenges companies face in handling regulatory differences when manufacturing targeted medicines.

32. 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.

33. X-Ray Inspection For Supplement Safety 2/6/2025

    Wellington Foods ensures dietary supplement safety using METTLER TOLEDO’s X37 X-ray system, which detects contaminants, and meets regulatory standards with high-speed, precise inspection technology.

34. Process Liquids And Buffers Offering 5/2/2024

    Whether you are a researcher, scientist, or industry professional, this video will provide valuable insights into our large volume liquids manufacturing capabilities.

35. The Future Of Compliance, Efficiency, And Data Integrity 5/5/2025

    Explore how eValidation revolutionizes the pharmaceutical industry by enhancing compliance, efficiency, and data integrity, as well as its indispensable role in modernizing traditional validation methods.

36. EMA Adopts Collaborative Approach With ATMP Guideline Update 7/17/2024

    The EMA has taken a collaborative approach with its updated ATMP guideline, aiming to streamline development and clarify regulatory expectations for cell and gene therapies across Europe's landscape.

37. Selecting The Best Deterministic Method For Your CCIT Project 3/31/2025

    Container Closure Integrity Testing (CCIT) ensures drug sterility, evolving with regulatory updates like USP <1207>. Deterministic methods are preferred over probabilistic ones to maintain product integrity.

38. Unpacking FDA's Final Rule To Regulate LDTs 3/14/2025

    Discover how the FDA's rule redefines diagnostic testing by classifying laboratory-developed tests (LDTs) as medical devices to ensure stricter oversight and consistent standards for safety and efficacy.

39. Why Perform A D-Value Study? Reference Review 10/31/2024

    Understanding how a product influences microorganisms' resistance is crucial. Read about relevant standards and references as well as recommendations for performing product D-value studies.

40. A 5-Step Guide To Achieving Your Biosimilar Milestones On Time 3/24/2025

    As the biologic patent cliff looms, biosimilar developers must strategically plot their approach to development and manufacturing to secure a corner of their market and reach their target patients.