RGAF 6300 - Compliance in Regulatory Affairs

Credits: (3)
Typically Taught Spring Semester: Full Sem - Online
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).
Pre-requisite(s): RGAF 6000.