BIOE 225 - cGMP Good manufacturing practice and regulatory affairs for bioengineers fall

Institution:

Lehigh University

Subject:

Description:

Review of the principles of the Food and Drug Administration including its history, mission and applied regulations. Understanding of how the FDA works with industry and is integral to the development of new products and technologies. Review and critique of case studies in various parts of the biomedical industry to see how FDA regulations are applied. Validation and analysis of products using failure mode analysis.

Credits:

1.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.lehigh.edu

Phone Number:

(610) 758-3000

Regional Accreditation:

Middle States Association of Colleges and Schools

Calendar System:

Semester

The Course Profile information is provided and updated by third parties including the respective institutions. While the institutions are able to update their information at any time, the information is not independently validated, and no party associated with this website can accept responsibility for its accuracy.