BMSC 3701 - Global Regulatory and Legal Requirements of Quality

3 Credit Hours

Pre/Corequisites: Prerequisite: Admission to the Quality Assurance in Life Science Industries Certificate.
Description
In this course, students will understand the role of regulators with an overview of regulations as stated in the U.S. Code of Federal Regulations (CFR), EudraLex Directives and Annexes, and Emerging Market regulations for the pharmaceutical, medical device, biotech, animal health and consumer goods industries. The faculty will demonstrate the relationship between regulatory requirements and legal accountability while introducing fundamental concepts in the regulations related to clinical trial development, management, ethics, data integrity, data security, privacy, change control and validation. Topics such as the role of guidance documents and industry standards will be reviewed, and case studies utilized to support the program. Global Scholars Course. Course may not be repeated for credit.