GMP Change Control Process

Change Control is a requirement of all regulatory agencies and authorities worldwide. It is a critical GMP function that must be addressed daily. The value of identifying and tracking change is to prevent unintended consequences, remain in proper process alignment, and avoid any alteration of the products’ Safety, Identity, Strength, Purity, and Quality (SISPQ). Many aspects of an operation are affected by change control making it imperative to properly assess, analyze, risk assess and plan for the change requested as part of the change control process. This fully accredited 12-hour course will provide an in-depth examination of what constitutes a change, who is responsible, and who participates in each step of the process. This course also covers the US FDA terms and exclusions regarding change control that have been implemented over the past few years.