Overview: Statistical Applications - Use of a statistician or person with adequate statistical training (not just 6 Sigma) to develop the experimental design and the statistical methods / models needed to measure and evaluate process capability, uniformity and on-going stability. Generate A Sense of Control - Process design and development, when assessed by the statistician, should anticipate significant sources of variability and establish statistically significant means of detection, control and mitigation strategies as well as initially finding a means of defining the alert limits and action limits that will most likely change as the process moves into a routine operation and now provides SQC and 6 Sigma opportunities. Too often, as sited in a variety of 483s, 6 Sigma was used to establish limits during development which is a significant statistical error.Create ConsistencyEnhance Process UnderstandingMeet Industry RegulationsWhy Should You Attend: Process knowledge and understanding is the basis for establishing and approach to process control for each unit of operation specific to equipment variables in order to generate overall process control needed for validation. The current majority of serious warning letters and consent decrees have been issued against companies with years of experience but an overall miscomprehension of the validation expectations. Is a validated process that has a significant number of OOS batches considered a validated process? A system or systems for detecting unplanned departures from the process as initially designed or currently operated is essential to accomplish this objective.