INSIGHTS ON QUALITY CONTROL

• Lessons From FDA 483s And Warning Letters: Cleanroom Compliance

  Learn critical lessons from FDA 483 observations and Warning Letters to proactively address common GMP cleanroom compliance failures and build an inspection-ready facility.

• Monitoring Microbial Contamination Of Mammalian Cell Cultures

  Mammalian cells are widely used to produce complex processed molecules. Explore a system that effectively detects microbial contamination in mammalian cell cultures and utilizes a newly formulated lysis buffer.

• Accelerate Biologics Product Release With Seamless Viral Testing

  Explore viral safety testing for biologics, focusing on prevention, detection, and removal strategies, updated regulatory guidance, and common challenges in unprocessed bulk testing.

• Elevating Environmental Monitoring Trending: From Data To Insight

  Move beyond raw data by using heat maps and site-specific limits to identify contamination hotspots. Transform your environmental monitoring into a proactive strategy for operational excellence.

• Ensuring Consistent Quality In Pharmaceutical Water For Injection (WFI) Systems Presentation

  3/5/2026

  Maintaining high-purity water is vital for pharmaceutical production. Explore key strategies for system design, risk mitigation, and rigorous process control to ensure consistent regulatory compliance.

• Empowering Glove Integrity Testing: Successful End User Training On The Esco IntelliGlove Tester (EIGT) In Bangladesh

  3/19/2026

  Advanced wireless testing ensures glove and barrier integrity in sterile manufacturing. These tools support ISO compliance and Annex 1 standards to strengthen contamination control.

• CPhI North America 2026: CDMO Partnerships With Mikart

  4/30/2026

  Event-driven blogs highlighting how sponsors can evaluate CDMO partnerships, outsourcing strategies, and formulation development discussions across major 2026 industry conferences.

• Cloud Migration In Regulated Environments: Validation Implications And Best Practices

  3/27/2026

  Cloud adoption is essential for BioPharma growth, offering scalable tools for faster research. Success requires a risk-based approach to ensure data integrity and GxP compliance during the shift.

• Filling The Sterility Testing Gap: Traceability And 21 CFR Part 11 Compliance

  6/6/2024

  Watch to learn about a solution that offers digital information for every stage of a sterility test while remaining compliant with 21 CFR Part 11.