VALIDATIONS

Catalog description

The BIOT 240 course introduces the topics of qualification, certification and validation of facilities, trials and tests, preventive maintenance, SPC (Statistical Process Control) validations and continuous processes and cleaning processes that apply to the drug industry, medical devices and food. The course emphasizes the general methodology of validation processes and the validation cycle for applications in equipment, instrumentation, and machinery used in laboratories and manufacturing within an environment regulated by the FDA. Emp hasis is placed on the development of critical thinking skills and quantitative reasoning, through the analysis of exercises/problems or case studies, which allow the student to solve based on scientific reasoning. Will use and ethically handle statistical data for improvements in the efficiency and effectiveness of industrial processes .