RGAF 6300 - Compliance Regulatory Affairs

Institution:

Weber State University

Subject:

Description:

This course focuses on regulatory affairs compliance strategies and guidelines. Topics included are regulatory compliance, risk management, bioethics, quality assurance, and required reporting. Students will identify and assess regulatory requirements, policies and guidelines associated with good practice (GXP) regulatory compliance issues. Students are required to critically analyze regulatory compliance issues and develop implementation strategies for ensuring regulatory affairs compliance in medical product manufacturing, development, and marketing. Students will need to demonstrate effective written communication skills required to develop regulatory communications using root cause analysis and corrective and preventive actions (CAPAs).

Credits:

3.00

Credit Hours:

Prerequisites:

RGAF 6000

Corequisites:

Exclusions:

Level:

Instructional Type:

Lecture

Notes:

Additional Information:

Historical Version(s):

Institution Website:

www.weber.edu

Phone Number:

(801) 626-6000

Regional Accreditation:

Northwest Commission on Colleges and Universities

Calendar System:

Semester

General Education

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