INSIGHTS ON REGULATORY COMPLIANCE

• Boston Scientific: Enterprise Asset Management

  Examine how Boston Scientific uses RAM to centralize asset management to boost compliance, efficiency, and visibility for maintenance, calibration, and validation across facilities.

• Aiming For Success In Early mAb Process Development And Beyond

  Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.

• The GxP AI Podcast: Unveiling the AI Model Validation Cheat Sheet

  Discover how AI is revolutionizing biotech manufacturing as Toni and Christian reveal the story, strategy, and regulatory impact behind their innovative AI model validation cheat sheet.

• Safeguarding Quality In Parenteral Drug Manufacturing

  Find out how vision inspection software helps injectable drug manufacturers meet USP <790> standards by improving defect detection, ensuring data integrity, and eliminating paper-based risks.

• What Are PFAS And How Do They Impact The Biotech Industry?

  9/13/2025

  Forever chemicals pose rising health risks and regulatory challenges. Learn how increasing restrictions on fluorinated compounds could reshape manufacturing, packaging, and sustainability strategies.

• 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.

• Gaining A Competitive Edge Through Regulatory Compliance Confidence

  12/10/2025

  Achieving regulatory compliance confidence is paramount for safety and competitive advantage. Adherence to standards and robust risk mitigation are essential to avoid delays and detrimental outcomes.

• Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials

  1/24/2024

  Improve your commercial manufacturing process with advice from regulatory and raw materials experts on the development journey from pre-clinical to licensure.

• Top Safety Considerations In Biopharmaceutical Manufacturing

  4/16/2025

  Understanding top safety concerns, from combustible material handling and chemical exposure to HPAPIs, is the first step toward preventing accidents in biopharmaceutical manufacturing environments.