Industry Collaboration & Consensus on Ethylene Oxide Residual Reduction, Risk-Based Approaches to Selection & Validation of Sterilization Modality to Meet Increasingly Complex Regulatory Requirements including FDA Parametric Release, Numerous ISO Standards and EU MDR
Current focus on potentially harmful levels of residuals resulting from the use of Ethylene Oxide (EO) sterilization methods have resulted in many medical device manufacturers and sterilization executives considering alternative modalities of sterilization, as well as risk-based approaches to reducing residual levels following EO sterilization. As organizations explore additional opportunities for product sterilization, considering FDA regulations and securing parametric release, meeting ISO standards including 13485, 10993, 17664 and 14971 and at the same time optimizing and validating cycles, are at the forefront of importance. Throughout, sessions will focus at a high level on the practical methods for risk-based approaches to testing and validating sterilization cycles and processes, with a focus on collaboration across the organization to highlight the importance of comprehensive sterilization practices.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | email@example.com