TE1081 - Pharmaceutical Validation Processes

Course Description

This course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. This course also reviews applicable definitions and descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on.