Process time vs. cycle time is a discussion that comes up often for newcomers to Six Sigma. Understanding these principles and how they apply to your time management is vital. Failing to grasp these ...

This webinar will describe the new Process Validation Life-Cycle Approach as defined in the revised FDA guideline. The three stages will be described in detail including: Process Design, Process ...

Performance metrics for processes are an area of much regulatory interest currently. There isn’t always a readily available clear definition of what is needed, however, and guidance from regulators is ...

Process capability indices (PCIs) have long served as crucial metrics in assessing the performance and quality of manufacturing processes. Recent advances in statistical estimation techniques have not ...

The authors desribe the three-stage approach to validation that is outlined in the new guidance and discuss questions surrounding implementation. The regulatory basis for process validation is ...