INSIGHTS ON REGULATORY COMPLIANCE

• Lessons Learned From Implementing The FDA's CSA Guidance: Summarizing

  Companies adopting CSA methodologies are not achieving the efficiencies they expected from the new guidance. This series identifies issues found during CSA implementations and how to avoid them.

• Trends In Next-Generation Delivery Technologies

  Learn how lipid nanoparticles are enabling a new generation of engineered cell therapies with a push toward more complex cell engineering and gene editing for allogeneic therapies.

• A Straightforward Path Toward Regulatory Compliance, Data Integrity, And Computer Systems Validation

  Learn practical strategies for validating microbial identification systems in cGMP. Understand regulatory guidance and master a complete Computer Systems Validation plan for full compliance.

• Pathogen Detection And Characterization

  Unlock high-quality transcriptome data from degraded or low-input samples with a 6.5-hour workflow and enhanced sensitivity for rare transcripts and viral detection, even from FFPE tissues.

• Automated Bioburden Testing Solution

  11/7/2025

  Automation is transforming microbial quality control labs, boosting productivity, minimizing errors, and ensuring data integrity. Discover how digitalization is driving Pharma 4.0 and reshaping lab workflows.

• Effective Contamination Control

  6/16/2025

  Discover key strategies for contamination control in cleanrooms, as well as explore contaminant sources, behaviors, and best practices for cleaning and removal to ensure high standards of product and process quality.

• The Role Of IV Bag Inspection In Drug Manufacturing

  2/5/2025

  Advanced IV bag inspection technologies ensure patient safety and regulatory compliance in drug manufacturing. Learn more about automated leak detection and quality control innovations to optimize your business.

• Validation Of A Sterilization Process: Part 3

  9/9/2025

  Explore the full scope of sterilization activities and gain key insights into cycle development and validation using BI and BB methods to ensure product sterility and regulatory compliance.

• Reduce Batch Failure Risk With An Innovative Platform

  6/11/2025

  Enhance reliability in cell therapy manufacturing with an innovative platform. Discover how the closed system and automation reduce operator errors through smart monitoring, pre-checks, alarms, and detailed batch reporting.