

It starts when a researcher wants to mathematically describe the relationship between some predictors and the response variable. Let’s review some common statistical methods for selecting models, complications you may face, and look at some practical advice for choosing the best regression model.

Trying to model it with only a sample doesn’t make it any easier. It is important to demonstrate an understanding of the process and characterize how it responds to various inputs within process design.Ĭhoosing the correct linear regression model can be difficult. Goal: Design a process suitable for routine commercial manufacturing that can consistently deliver a product that meets its quality attributes. If you don’t yet have Minitab, try it free for 30 days. You can use Minitab Statistical Software to run any of the analyses here. Let’s explore the stage goals and the types of activities and statistical techniques typically conducted within each. The FDA recommends three stages for process validation.

According to FDA guidelines, process validation is “the collection and evaluation of data, from the process design state through commercial production, which establishes scientific evidence that a process is capable of consistently delivering a quality product.” Process validation is vital to the success of companies that manufacture pharmaceutical drugs, vaccines, test kits, and a variety of other biological products for people and animals.
