Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines 2017

Topics

• The difference between confidence and tolerance intervals
• Linear and other quantitative measurement procedures
• Laboratory/clinical data results based on risk management and design space issues
• The sensitivity of the sample size in given procedures
• Relevant FDA requirements and ICH guidelines
• Alternative approaches to statistical process control in reference to data distributional formats

Who should Attend

• Quality Professionals
• Quality Managers
• Research Scientists
• Assay Development Scientists
• Laboratory Data Managers
• Clinical/Laboratory Data Analysts