Graduate Certificate in Chemistry, Manufacturing, and Controls
The Chemical, Manufacturing, & Controls (CMC) graduate certificate is designed to prepare the student for working in the highly regulated medical product industry in the specialized area of CMC.
Upon completion of the certificate program, students will:
- Be knowledgeable in laws, regulations, and guidelines related to drug approval requirements,
- Know 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
- Be knowledgeable of the key aspects of the manufacturing process as it relates to regulatory review and inspection policies
- Apply established principles of the submission process that regulatory authorities use to evaluate new medical product applications
Designed to increase knowledge in the regulatory framework and to develop competencies in regulatory (including sub-categories), clinical, and government processes that are critical in helping assure the development, manufacturing, and marketing of safe and effective medical products around the world. Course and project work enhance competencies such as critical thinking, problem-solving, communication, and strategic thinking needed to be successful in the medical industry.
Regulatory Affairs (RA) professionals (a collective term used for all specializations) are employed in industry, government, and academia and provide a range of services related to the regulation, development, manufacturing, and marketing of pharmaceuticals, medical devices, in vitro diagnostics, biologics, biotechnology, nutritional products, cosmetics, and veterinary products. There are many specialized areas within regulatory science and the proposed certificate will address one of those areas.
Students gain specialized knowledge and regulatory expertise for working in the medical products industry.
Roles and Responsibilities of a Chemistry, Manufacturing & Controls (CMC) Professionals include:
· Lead preparation of the quality/CMC section of new drug applications, abbreviated new drug applications, investigational new drug applications, new animal drug applications, abbreviated new animal drug applications, investigational new animal drug applications
· Manage all regulatory aspects related to drug substance (API) and drug product including changes in manufacturing, testing, and stability
· Member of product development project teams and commercial product stewardship teams
· Liaise with regulatory authorities to communicate and negotiate submissions and approvals
· Support management in due diligence and strategic business activities related to product development and acquisition
· Maintain current knowledge of the regulatory environment
· Support the quality group during inspections
· Ensure compliance with regulations
Southern Association of Colleges and Schools Commission on Colleges