Regulatory Affairs Compliance
General
Prefix
RAS
Course Number
635
Course Level
Graduate
Department/Unit(s)
College/School
College of Science and Engineering
Description
Students will be knowledgeable about the regulations associated with device product listing, facility registration, product complaint management, aware of other considerations associated with compliance such as liability, root cause analyses, effective communication, and ethical considerations.
Prerequisites
Credits
Min
3
Max
3
Repeatable
No
Goals and Diversity
MN Goal Course
No
Cultural Diversity
No
Learning Outcomes
Outcome
Assess business and legal responsibilities associated with device product listing, facility registration, post-market surveillance and complaint handling, MDRs for adverse events, recalls/corrections/removals, import/export, and medical device tracking.
Outcome
Develop adverse event documentation that complies with quality regulations.
Outcome
Implement the concepts and application of corrective and preventive action (CAPA) and root cause analyses in monitoring field performance of healthcare products.
Outcome
Explain regulatory issues clearly and implement strategies for effective communication of negative information to multiple audiences.
Outcome
Examine labeling and advertising for regulatory compliance.
Outcome
Develop strategies for minimizing liability and present alternative approaches.
Outcome
Identify stakeholders associated with global product compliance.
Outcome
Research and advise on business, technical and ethical considerations as it relates to global product compliance, field actions, and enforcement actions.
Dependencies
Programs
RAS635
is a
completion requirement
for: