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

Topics

• The difference between confidence and tolerance intervals
• Linear quantitative measurement procedures and sources of error
• Laboratory/clinical quality control based on risk management
• The appropriateness of the effect of sample size in given procedures
• FDA requirements and ICH guidelines
• Statistical process control

Who should Attend

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