INSIGHTS ON REGULATORY COMPLIANCE

• The Next Leap In Pharma Manufacturing

  Explore how Industry 4.0 integration transforms pharma manufacturing through connected systems, data-driven insights, and predictive, compliant operations.

• How To Adopt CSA For Streamlined Computer System Validation

  Discover how the FDA’s Computer Software Assurance guidance modernizes validation by reducing compliance burdens and fostering innovation through a streamlined approach to system validation.

• Effective Contamination Control

  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.

• Simple In-House Mycoplasma Testing Method For Regulatory Expectations And Rapid, Confident, And Actionable Results

  In this webinar, we present an overview of worldwide regulatory guidance for mycoplasma testing, as well as a mycoplasma testing method that has been accepted by regulatory authorities worldwide across various therapeutic modalities.

• The Pathway To Operational Readiness

  6/24/2025

  Ready to ensure your facilities, systems, and teams are prepared for success from Day One? Discover a proven framework to accelerate operational readiness, mitigate risks, and achieve sustainable results.

• Simplifying Final Filling - Single-Use Transfer And Filling Solutions

  8/7/2025

  Explore a single-use system for secure final filling and aseptic transfer that is designed to boost productivity, minimize contamination, and maximize product recovery.

• Understanding cGMPs For Phase 1 Investigational Drugs

  8/15/2025

  Learn how a structured, risk-based approach to early-phase manufacturing can help streamline processes, reduce costs, and accelerate the path to first-in-human trials while meeting FDA cGMP guidelines.

• Sustainability By Design In API Manufacturing

  7/29/2025

  Explore the urgent need for sustainability in small molecule API manufacturing, as well as reveal regulatory drivers, green chemistry innovations, and practical strategies to reduce emissions.

• Reducing Costs & Risks: A Pharma Guide To FTZ Subzones For U.S. Drug Manufacturing

  2/11/2025

  Utilized wisely, FTZs and subzones can be tools for cost savings and can enable pharma companies to leverage the benefits of American manufacturing.