Classes may be offered during the day, evening, online, or a combination. Students should refer to Self Service for the availability of classes.
ISC-121: Environmental Health & Safety
This course covers workplace environmental, health, and safety concepts. Emphasis is placed on managing the implementation and enforcement of environmental health and safety regulations and on preventing accidents, injuries, and illnesses. Upon completion, students should be able to demonstrate an understanding of basic concepts of environmental health and safety.
Requisites:
None
Total Credits:3
Class Credits:3
Lab Credits:0
Clinic Credits:0
ISC-278: cGMP Quality Systems
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.
Requisites:
None
Total Credits:2
Class Credits:2
Lab Credits:0
Clinic Credits:0
ISC-280: Validation Fundamentals
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.
