Insights On Quality Assurance

31. Drive Innovation With Validation 4.0 7/1/2025

    Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.

32. How Robotic Isolator Technology Aligns To Annex 1 Principles 4/28/2025

    Robotic gloveless isolators provide exceptional automation to eliminate human intervention and reduce contamination risk. Discover how they ensure compliance with the EU Annex 1 guideline to enhance sterility, precision, and monitoring.

33. Achieve Harmonization By Integrating Safety, Environmental, And Quality Workflows 2/7/2025

    Kimberly-Clark Corporation integrated its safety, environmental, and quality processes into a unified system. Discover how they enhanced efficiency, reduced redundancies, and achieved global standardization.

34. Driving Continuous Improvement: Pushing Through The Barriers To Change 10/15/2024

    Discover how continuous improvement drives efficiency in pharmaceutical manufacturing. Learn strategies to harmonize processes and reduce environmental impact in this thoughtful exploration.

35. 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.

36. 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.

37. Pressure Testing Your Readiness To Ensure GMP Batch #1 Success 5/28/2024

    Watch as an expert from an industry-leading CDMO provides insights into the crucial factors, challenges, and tech transfer methods needed to achieve right-first-time readiness and success.

38. Continued Process Verification: Driving Consistent Quality In Manufacturing 12/9/2024

    Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.

39. A New Framework For Identifying Nitrosamine Risks And Derisking Products 6/18/2024

    Examine a new methodology that holds significant promise for identifying APIs at risk for NDSRI formation, enabling manufacturers to prioritize risk mitigation strategies and ensure compliance.

40. Supply Chain Corrective Action Report Checklist 2/7/2025

    Discover how to shape a corrective action plan that provides a structured method for resolving supply chain issues, emphasizing root cause analysis, accountability, and continuous improvement.