INSIGHTS ON REGULATORY COMPLIANCE

• Laying Supply Chain Foundations That Bring Confidence To Compliance

  Compliance with EU GMP Annex 1 requires a strategic CCS. Learn how a framework based on people, communication, process, and continuous improvement enables systematic, long-term compliance.

• Process Validation For Pharmaceutical Manufacturers

  Manufacturers must validate their processes to meet FDA standards and protect consumer safety. Explore how process validation ensures consistent product quality and is a cornerstone of compliance.

• Translating Study Reports – A GLP Draft Guidance

  The FDA has provided guidelines for the translation of studies conducted by non-US testing facilities, including an expectation that the translated report include a statement of certification requirements.

• Re-Engineering A Complex Process For FDA Compliance

  Discover the strategies that helped a company navigate a complex and shifting regulatory landscape to rapidly re-engineer a COVID-19 vaccine manufacturing process for FDA compliance.

• What Is OPC Counting Efficiency?

  6/24/2025

  Ensure cleanroom air quality with optical particle counters. Explore how OPCs work, their performance metrics, and key considerations for choosing the right one.

• Revolutionizing Drug Manufacturing: A Closer Look At GMP Inspections

  12/20/2023

  Learn about the collaborative efforts among global regulators currently underway to address drug availability challenges following the supply shortages and disruptions from the COVID-19 pandemic.

• Streamline Drug Development With A Lab Informatics Platform

  8/13/2025

  Learn how a tiered approach to ADME-Tox studies can help researchers navigate early-stage preclinical research and mitigate the risk of costly failures in drug development.

• 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.

• Environmental Monitoring Vs. Good Aseptic Technique

  4/23/2024

  Review the standards and regulations promoting a cohesive environmental program, and explore manual compounding in laminar flow hoods, through to filling lines, in both open and closed systems.