Graduate Certificate in Chemistry, Manufacturing & Controls
I have international experience in regulatory affairs and quality assurance management, working under multiple regulatory systems such as the FDA and European Medicines Agency. This informs my work and teaching and allows me to provide an informed and complete perspective.
The Chemistry, 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
The University of Georgia is accredited by the Southern Association of Colleges and Schools Commission on Colleges (SACSCOC) to award baccalaureate, master’s, specialist, and doctoral degrees. The University of Georgia also may offer credentials such as certificates and diplomas at approved degree levels. Questions about the accreditation of the University of Georgia may be directed in writing to the Southern Association of Colleges and Schools Commission on Colleges at 1866 Southern Lane, Decatur, GA 30033-4097, by calling (404) 679-4500, or by using information available on SACSCOC’s website (www.sacscoc.org).
Total Hours Required to Earn a Graduate Certificate in Chemistry, Manufacturing & Controls: 14 (credit hours) Maximum Hours Transferable into Program: N/A
Students who are not currently enrolled at UGA should apply to the graduate school for the Graduate Certificate program in Chemistry, Manufacturing & Controls and are not required to take entrance exams and submit letters of recommendation. Preference will be given to applicants with a degree in sciences, healthcare, or engineering. Preference will also be given to applicants employed in the pharmaceutical, medical device, and biotechnology industries, or related fields.
Applying to the Certificate in Chemistry, Manufacturing & Controls Program is a two-step process. You will need to submit our departmental application and an application to the UGA Graduate School.
Résumé or curriculum vita – Upload to the Graduate School application.
Statement of Purpose – Submit to the Graduate School online in your application
Transcripts – Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission.
Letters of Recommendation – Submit two letters of recommendation online to graduate school. Letters should be from individuals who can evaluate the applicant’s scholarly ability and potential for success in a graduate program. The application will prompt your recommenders to submit their letters electronically.
International Applicants – must also submit TOEFL or IELTS scores.
Fall: June 1
Spring: November 1
Fall: April 15
Spring: October 15
Tuition & Fees
Tuition rates and student fees can change each year.
Based on credit hour cost, a person completing this program at the recommended pace would pay $10,080 in tuition.