BIOE 8660 - Reg Reqts of Quality-MedTech

Institution:

Clemson University

Subject:

Bioengineering

Description:

This course provides students with an understanding of the United States and international regulations for the medical device, pharmaceutical, and life science industries. Students are introduced to fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control, and validation.

Credits:

3.00

Credit Hours:

Prerequisites:

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.clemson.edu

Phone Number:

(864) 656-4636

Regional Accreditation:

Southern Association of Colleges and Schools

Calendar System:

Semester

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