INSIGHTS ON REGULATORY COMPLIANCE

• Why And Where To Monitor In Aseptic Processing Areas

  Annex 1 mandates a risk assessment to identify optimal sample point locations. Explore factors in risk assessment, equipment selection, and system design to maximize data value.

• How Bend Bioscience Standardized Operations And Boosted Compliance

  Discover how Bend Bioscience replaced its outdated CMMS with RAM to achieve rapid compliance, boost efficiency across facilities, and cut operational costs by 25%.

• Automation-Assisted Washing Of Multicellular 3D Spheroids

  Automated washing of 3D spheroids improves consistency, reduces cell loss, and streamlines staining workflows. See how this approach enhances reproducibility and throughput in microplate-based assays.

• A New Framework For Identifying Nitrosamine Risks And Derisking Products

  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.

• Accelerate Production Through Digital Commissioning And Qualification

  12/17/2024

  Watch to learn how digital validation streamlines commissioning and qualification (C&Q), improving productivity, compliance, and cost-efficiency across your organization.

• Developing A Comprehensive Regulatory Approach For LNP Drugs

  2/26/2024

  The path to regulatory approval for LNPs demands carefully considered strategies. By adopting proactive and strategic approaches, developers can overcome regulatory hurdles on the path to approval.

• How Ergonomics And Cleaning Ease Reduce Repetitive Stress Injuries And Contamination In Pharmaceutical Lab Workflows

  2/3/2025

  The repetitive nature of routine laboratory procedures can put technicians and scientists at risk for repetitive strain injury. Routine activities often include reoccurrence of the same movements over and over, which can take a toll on hands, wrists and shoulders and ultimately can lead to serious damage. Choosing the right tools can make all the difference.

• PUPSIT As Part Of A Contamination Control Strategy (CCS)

  8/21/2024

  Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.

• Ensuring AI Compliance In Life Sciences: 5 Critical Requirements

  7/24/2025

  Life sciences manufacturers face growing pressure to adopt AI while staying compliant. Discover five key areas to evaluate AI tools and how to simplify adoption with regulatory assurance.