INSIGHTS ON REGULATORY COMPLIANCE

• Navigating Cleanroom Compliance For Safe Material Transfer

  Watch to explore various aspects of environmental monitoring essential for the transfer of materials into controlled areas as well as recent advancements that can facilitate this task.

• The Crucial Role Of Cleaning In Effective VPHP Decontamination For Isolators

  Effective isolator cleaning is crucial for vapor phase hydrogen peroxide (VPHP) decontamination. Proper tools, techniques, and training ensure sterility, and regulatory compliance.

• Implementing A Risk-Based Approach To Calibration

  Discover why companies may benefit from a risk-based approach to calibration, utilizing information from User Requirement Specifications and other documents created during process development.

• How Non-Destructive Headspace Analysis Advances CCI Testing

  Opting to use headspace analysis to assess container closure integrity (CCI) for your drug packaging ensures robust data and CCI assurance to protect your product and maintain regulatory compliance.

• Overview Of Biological Indicator And Sterilization Monitoring Systems

  7/2/2024

  Watch to explore the use and proper placement of biological indicators in hydrogen peroxide decontamination processes.

• Unlocking Digital Transformation: Embrace CSA For Rapid Innovation

  7/16/2025

  Gain valuable insights from industry leaders on how life sciences manufacturers can embrace innovation and digital transformation through the FDA’s CSA guidance.

• Analytical Strategies To Address Common Development Challenges

  4/30/2024

  Discover analytical strategies designed to address challenges occurring during development of new molecular formats such as chain assembly, multiple-MoAs, and diverse post-translational modifications.

• How To Get Products To Patients Faster With A Connected QMS

  8/14/2025

  BioBridge Global faced challenges with paper-heavy processes that risked errors and delays. Discover how digital solutions streamlined their operations and improved regulatory efficiency.

• Optimizing Contamination Control: Strategy Planning And Execution

  7/25/2025

  A robust contamination control strategy using a plan-do-study-act framework ensures compliance, product quality, and operational efficiency in biopharmaceutical manufacturing facilities.