INSIGHTS ON REGULATORY COMPLIANCE

• Reduce Batch Failure Risk With An Innovative Platform

  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.

• Navigating The Nuances Of Process And Analytical Development

  This panel discussion explores the intricate challenges in transitioning cell therapy processes from research to Good Manufacturing Practice compliance.

• From Compliance To Process Control: Enabling Preventive Monitoring Through Smart CPV

  Learn to leverage Continued Process Verification (CPV) and analytics for early detection of process drift, enabling preventive monitoring and enhancing overall process robustness.

• A Rheologist's Guide To Regulatory Confidence

  Explore key rheology concepts and terminology, and learn how to generate the required rheological profiles using high-performance instruments.

• Just Press Start To Begin Manually Counting Particles In Your Cleanroom

  5/6/2024

  With the press of a button, you can immediately start taking particle counts in your cleanroom using a portable particle counter for easy cleanroom monitoring.

• Combination Products: Navigating Regulatory Strategy, Design Verification

  5/19/2025

  Delve into the intricacies of combination products and the regulatory expectations, including risk-based determination, evaluation, and documentation approaches for performance requirements.

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

  6/9/2025

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

• 5 Must-Haves For Electronic Batch Records In Life Sciences

  6/17/2025

  Companies still relying on paper-based manufacturing are falling behind. Examine how digital transformation boosts efficiency and reduces errors in this essential shift toward smarter operations.

• Scientific Insights Into VHP Biodecontamination And BI Quality Management

  9/24/2025

  VHP biodecontamination ensures aseptic manufacturing, but BI variability challenges validation. Addressing rogue BIs and regulatory shifts strengthens contamination control and process reliability.