Process monitoring, control and improvement has been at the heart of quality management for decades. The methodology continues to develop and has moved into a new era with the widespread availability of online data collection systems. This development creates the need for better utilization of the collected data for process monitoring, control and improvement.This presentation […]
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Although the concept was introduced in 2011, industry still struggles with the complex challenges of our rapidly change quality and technical environments. KENX is proud to present this virtual training that help you master a risk-based […]
KENX Introduces Virtual Series for Staying Connected, Informed & InspiredDuring this time of COVID-19 it is everyone’s responsibility to support the effort to stay connected, informed and inspired. Because of our global position, our remarkable industry possesses extensive knowledge, experience and wisdom that can, and will, be used to resolve this pandemic. Many of the […]
Join Thomas Miller, Senior Enterprise Architect, and Christopher Robitaille, CTO, of Azzur Technical Consulting Services for an in-depth discussion on Bringing Validation into the IT Architecture Process. This webinar discusses the IT architecture process and its benefits to validation, understanding the importance of the layered defense and its effect on your architecture. In addition, this tutorial […]
FDA’s 3-Stage life cycle approach is the backbone of all validation and is globally recognized as the gold standard. Statistics and statistical methods are mentioned 14 times throughout FDA’s 19-page Process Validation Guidance. Although the concept was introduced in 2011, the industry still struggles with using statistics effectively throughout the validation life cycle. KENX is […]
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