Industrial Science (ISC)

This course introduces the principles of industrial safety. Emphasis is placed on industrial safety and OSHA regulations. Upon completion, students should be able to demonstrate knowledge of a safe working environment and OSHA compliance.

This course focuses on the development, implementation, and ongoing maintenance of a quality system in a cGMP environment. Topics include the cGMP standard, components of cGMP quality systems, quality function roles and training, development of documentation such as SOPs, and system review procedures. Upon completion, students should be able to identify the components of a quality system and develop a quality system manual utilizing the cGMP standard.

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.