Define installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ), and the typical project design documents are required to prepare such testing protocols. Describe the cleaning validation sequence and the basis for quantification limits and how to determine clean
End-of-Module Assignment Your end-of-module assignment is to clearly demonstrate your Knowledge and Understanding of the Quality Culture necessary to work in a GMP-regulated manufacturing environment, and that you personally understand the rules that govern manufacturing, the guidelines as to how the rules are applied, and the risk management tools to make scientific-based decisions. Assignment Requirements: […]