This course covers the fundamental concepts of components of a validation program in a cGMP environment. Emphasis is placed on FDA requirements concerning validation, types of validation, documentation, procedures, and the QA role. Upon completion, students should be able to discuss the purpose of validation, identify the steps in the validation process, and effectively utilize sample documentation.
Requisites:
None
Total Class Credits:
2 Class Credits: 1 Lab Credits: 2 Clinic Credits: 0
