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The Graduate Certificate in Quality Assurance Compliance equips you to manage compliance requirements for industry-specific regulations across the entire product lifecycle.
Through this program, students will gain the ability to:
Outline the key standards employed by the U.S. Food and Drug Administration (FDA) and international regulatory bodies to assess the safety and effectiveness of both current and emerging biomedical products used in U.S. healthcare
Apply compliance-related regulations and standards with expertise for biomedical products in global markets throughout their entire lifespan
Distinguish between various phases of the worldwide biomedical product commercialization process from regulatory and compliance viewpoints
Explain the core regulatory compliance and standards-based procedures required for manufacturing biomedical products to preserve the safety and effectiveness levels that earned their approval from the FDA and other international regulators