Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines 2017 is a seminar that covers topics such as:
- 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
Laboratory, Medical and Device Performance and Validation following Regulatory and ICH Statistical Guidelines 2017 brings together:
- Quality Professionals
- Quality Managers
- Research Scientists
- Assay Development Scientists
- Laboratory Data Managers
- Clinical/Laboratory Data Analysts