Overview

Graduate Certificate in Chemistry, Manufacturing & Controls

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. Degree-granting institutions 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).

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. Degree-granting institutions 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).

Cost

Tuition & Fees

Tuition and fees are subject to change.

Use the Estimated Cost Calculator on the Bursar's Office website for current tuition and fees. 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. Potential additional costs include textbooks, exam proctoring fees, and technology upgrades.

Financial Aid

Visit the Office of Student Financial Aid for information about financial assistance for the M.S. in Pharmacy programs.

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 professional growth and development. 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 printer may be required.
  • High-speed internet access.

Daily access to a computer with required specifications and a working knowledge of the Microsoft Windows Operating System, Microsoft Office Suite (including MS Word, Excel) Internet Explorer and Adobe Reader.

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

  1. Application - Submit online to the Graduate School Admissions. Application fee: $75 Domestic/ $100 International
  2. Select Campus - Online 
  3. Select Intended Program - CERG, Chemistry, Manufacturing & Controls (College of Pharmacy) [CERT_2MC] 
  4. Submit the Supplemental Application - Link to be provided -
    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
  5. Résumé or curriculum vita – Upload to the Graduate School application.
  6. Statement of Purpose - Submit to the Graduate School online in your application  
  7. Transcripts - Submit unofficial transcripts from all institutions attended as part of the online application. Send official transcripts after you are offered admission. 
  8. 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

International Applicants

  • Fall:  April 15

Curriculum

Program Structure

The program plan is ideal for working professionals and consists of 14 semester credit hours, delivered online.

Sample Part-time Schedule

Fall Term Spring Term Summer Term
  • Current Good Manufacturing Practices (PHAR6030E - 4 semester hours)
  • Quality Control and Quality Assurance (PHAR 6100E - 3 semester hours)
  • Chemistry, Manufacturing and Controls (PHAR6160E - 4 semester hours)
  • Process Control and Validation (PHAR6120E - 3 semester hours)

Student Handbook

 

Contact Information

Email us using the request for information form or call 1.844.842.3294

Email us using the request for information form or call 706-452-7948