Sampling a product or process and measuring a quality characteristic is an efficient way to make an inference about the quality of all products or the entire process. Simply put, if it is too expensive to measure everything, then you would be wise to sample and measure a subset. If you decide to sample, then comes the age-old question: “How much should I sample?”
Sampling is a key statistical method used for Design Control, Process Validation, CAPA, complaint monitoring, and for Receiving, In-Process, & Finished Device Acceptance. This workshop will discuss the recommendations of the guidance documents developed by the FDA and the Global Harmonization Task Force (GHTF) along with industry standards. It will also provide best practices applied in a wide variety of industry settings.