Graduate Certificate in Chemistry, Manufacturing & Controls
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.
Overview
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
· Support the quality group during inspections
· Ensure compliance with regulations
Accreditations
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).
College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education (ACPE).
Other online programs of interest
You also may be interested in these online programs:
Graduate Certificate Clinical Trials Design and Management
Graduate Certificate International Biomedical Regulatory Sciences
Graduate Certificate in Drug Safety and Pharmacovigilance
Master of Science (MS) in International Biomedical Regulatory Sciences
Admissions
Credit and Transfer
Total Hours Required to Earn a Graduate Certificate in Chemistry, Manufacturing & Controls: 14 (credit hours)
Maximum Hours Transferable into Program: N/A
Admission Requirements
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.
Application Checklist
- Application – Submit online to the Graduate School Admissions. Application fee: $75 Domestic/ $100 International
- Select Campus – Online
- Select Intended Program – CERG, Chemistry, Manufacturing & Controls (College of Pharmacy) [CERT_2MC]
- Submit the Supplemental Application – Certificate in Chemistry, Manufacturing and Controls Application (pdf) – Complete and email to regsciences@uga.edu or mail to the department:
Regulatory Affairs Graduate Education Program
The University of Georgia Gwinnett Campus
2530 Sever Road
Lawrenceville, Georgia 30043-4005 - 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.
Application Deadlines
Domestic Applicants
- Fall: June 1
- Spring: November 1
International Applicants
- Fall: April 15
- Spring: October 15
Cost
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.
Please use the Estimated Cost Calculator on the Bursar’s Office website to calculate one academic (Fall/Spring) year’s current tuition.
This program is an E-Rate program, so choose “yes” for the E-Rate line item within the calculator.
Online students pay the following fees: Connect UGA, Green, and Technology. The total for those fees in the fall semester of 2022 was $147 for students enrolled in exclusively online courses.
Potential additional costs include textbooks, exam proctoring fees, and technology upgrades.
The complete cost of attendance can be found at https://osfa.uga.edu/costs/.
Financial Aid
Visit the Office of Student Financial Aid for information about financial assistance.
Corporate Assistance
Consult your employer about the availability of tuition reimbursement or tuition assistance programs.
Military Assistance
Active duty military, veterans, and military families should visit Veterans Educational Benefits to take full advantage of available financial assistance and educational benefits.
University System of Georgia Tuition Assistance Program (TAP)
The purpose of TAP is to foster the professional growth and development of eligible employees. For more information, see Tuition Assistance (refer to the Distance Learning section).
Technology Requirements
- Computer with current operating system (Windows, Mac, or Linux). Additional peripherals such as webcam, headphones, and microphone are required.
- High-speed internet access.
Curriculum
Program Structure
The program plan is ideal for working professionals and consists of 14 semester credit hours, delivered online.
Courses
| Course | Title | Credit |
| PHAR 6120E | Process Control and Validation | 3 |
| PHAR 6160E | Chemistry, Manufacturing, and Controls | 4 |
| PHAR 6030E | Current Good Manufacturing Practices | 4 |
| PHAR 6100E | Quality Control and Quality Assurance | 3 |
Faculty
News & Events
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Contact Information
Contact us using the request for information form or call 706-452-7948.