INSIGHTS ON QUALITY ASSURANCE

• Seal The Deal: Mastering Vent Integration In Medical Devices

  Learn how precise vent placement and microfiltration design optimize performance in life science devices. See practical troubleshooting strategies and a real-world case study.

• FDA's CSA Guidance Is Final: What It Means For Your Validation Strategy

  Understand the FDA's shift from rigid CSV to risk-based software assurance. Binary risk classification and flexible testing approaches reduce validation timelines for production and quality.

• A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems

  One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.

• Monitoring Compressed Gases For Microbial And Particle Contamination

  There are several factors associated with active environmental microbial monitoring. Watch to learn how the EU GMP Annex 1 compliance focuses on microbial monitoring in cleanrooms.

• Select The Best Analyte: A Guide To Effective Mycoplasma Testing

  9/24/2025

  As you build a Mycoplasma testing strategy to ensure drug safety, there are three analyte types to choose from: live Mycoplasma, RNA, and genomic DNA, each offering distinct advantages.

• Seamless Process Transfer Using An In Silico Bioreactor Scaling Tool

  3/24/2025

  Transferring cell cultures between scales is challenging and error-prone. Discover a bioreactor scaling software that predicts optimal settings to enable efficient scale-up and progression to clinical studies.

• Top 3 Things To Consider When Designing A Risk-Based Cleaning Validation Process

  10/23/2024

  Learn how implementing a systematic approach to cleaning validation can significantly enhance compliance and improve your audit readiness.

• From Design To Delivery: Aseptic Filling Workcell

  3/20/2026

  Follow the build of a modern aseptic filling system, from precision assembly to installation. See how thoughtful engineering and sterility assurance come together to support flexible manufacturing.

• Method Development For Forced Degradation Of GLP-1 Agonist

  3/18/2026

  Gain insight into how a systematic approach reveals impurity behavior, strengthens selectivity, and refines chromatographic conditions to build a reliable degradation method for a GLP‑1 agonist.