The Chemistry, Manufacturing, & Controls (CMC) graduate certificate is designed to prepare the student for the working in the highly regulated medical product industry in the specialized area of CMC.

Upon completion of the certificate program, students will be able to:

  • Be knowledgeable in laws, regulations and guidelines related to drug approval requirements, Good Manufacturing Practices (GMP) and Quality by Design (QBD) principles
  • Outline the product development process for medical products
  • Locate information necessary to their role as CMC professionals
  • Describe the pre-approval and approval CMC requirements for new products, including the maintenance of those products after marketing
  • Be familiar with the complex interaction between regulatory requirements and development processes for new products
  • Knowledgeable of the key aspects of the manufacturing process as it relates to regulatory review and inspection policies
  • Apply established principles of submission process that regulatory authorities use to evaluate new medical product applications

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