INSIGHTS ON REGULATORY COMPLIANCE

• Human Factors Testing: Engaging End-Users In Med Device Development

  Explore the significance of human factors in the development of medical devices through an illustration of how important it is to incorporate the end users in the device development process.

• Quality Roundtable: Optimizing Biologics Manufacturing Processes With Raw Materials

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

• What Your Environmental Monitoring Isn't Telling You

  Explore overlooked contamination sources, like residues, poor housekeeping, and training gaps, which offer practical strategies to strengthen your contamination control program.

• Tackling Residual DNA Testing In Biotherapy Manufacturing

  Controlling residual host cell DNA is critical for the safety and efficacy of biotherapeutics. Learn about robust, highly sensitive analytical methods for effective DNA clearance and process control.

• Compressed Gas Contamination: Guidelines For Control In Aseptic Manufacturing

  10/18/2024

  Explore key guidelines for preserving the purity and quality of compressed gas, with an emphasis on contaminants, monitoring, and preventive maintenance practices.

• An Innovative Solution For Continuous Low pH Flow-Through Virus Inactivation

  11/5/2025

  Continuous biomanufacturing is reshaping how active pharmaceutical ingredients are produced. Learn how modular, automated virus inactivation solutions are helping manufacturers improve efficiency.

• Compliance To Confidence: Annex 1 For Small-Batch, High-Value Production

  10/3/2025

  Get strategies for meeting the updated GMP Annex 1 in small-batch aseptic filling. Learn about contamination control, quality management, and equipment design for high-value liquid and powder products.

• Control Strategies And Method Development For Nitrosamines In Peptide APIs And Drug Products

  11/26/2024

  Pharmaceutical scientists and engineers must advance robust, sensitive, and efficient nitrosamine detection and control methods to ensure regulatory compliance and safeguard public health in peptide-based drugs.

• Catalent's Journey Of Continuous Improvement For CSV Excellence

  3/19/2025

  Learn how organizations must continuously reassess validation processes and digital tools to ensure compliance, enhance efficiency, and support global scalability amidst evolving regulatory expectations.