Change Control: Regulations and Guidelines

In this program, we will focus on providing an in-depth understanding of performing change control and change management for organizations functioning within the life sciences industry (and related companies), including pharmaceutical and medical device manufacturers. Change control is a well-known good manufacturing practices (GMP) concept that focuses on managing change to prevent unintended consequences, maintain processes in a suitable state, such as in a “validated state,” and prevent any consequence of the change on the products’ Safety, Integrity, Strength, Purity and Quality (SISPQ). Change control has several different explanations, depending on the area to which the concept is applied.