Professionals knowledgeable in the principles and practice of regulatory CMC requirements are in high demand and hold positions of significant responsibility within the private and public sectors of the healthcare industry. The primary goal of this course is to provide students with an advanced background in the principles and requirements of regulatory CMC including Post-Approval reporting requirements, Deviation reporting, Inspection coordination and resolution, and Good Distribution Practices (GDP) practices. Through a series of lectures and case studies, this course will teach the critical thinking and judgment skills that are required for the development of CMC regulatory strategies and influence.(ALS 352)
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