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 […]
I. Plan for a Successful Gap Analysis• Define what is needed to complete the analysis• Develop the tools to conduct the Gap Analysis• Train your personnel to conduct the Gap Analysis• Define the scope of your Gap AnalysisII. Determine the Gap in Your Process Validation Program• Define the ideal where you would like to be• […]
