|
|
|
Mar 12, 2025
|
|
2025 - 2026 Catalog
Pharmaceutical Regulatory Affairs (PHRA-CT) - Certificate
|
|
 Return to: Degree Programs
Develop the expertise needed to navigate the complex regulatory landscape of pharmaceutical manufacturing with our Certificate in Pharmaceutical Manufacturing Regulatory Affairs. This advanced program provides comprehensive coursework covering the essential pathways of drug approval by the FDA, as well as the critical aspects of chemical and manufacturing controls and current good manufacturing practices (cGMPs).
Through this certificate program, students will gain a deep understanding of the regulatory requirements and industry standards that govern pharmaceutical manufacturing. They will be equipped with the knowledge and skills necessary to succeed in roles at drug manufacturing companies or regulatory agencies, where they will play a critical part in ensuring the safety, quality, and efficacy of pharmaceutical products.
Our program is designed to provide students with:
- In-depth knowledge of FDA approval pathways and regulatory requirements
- Understanding of chemical and manufacturing controls, including cGMPs
- Expertise in regulatory compliance and quality assurance
- Preparation for careers in pharmaceutical manufacturing, regulatory agencies, or related fields
Whether you are a working professional seeking to enhance your skills or a student looking to specialize in pharmaceutical manufacturing regulatory affairs, this certificate program will provide you with the advanced knowledge and expertise needed to succeed in this critical and dynamic field.
|
Program Outcomes
1. Describe regulatory issues associated with the manufacturing of pharmaceuticals before and after FDA approval.
2. Describe CMC requirements for the manufacture of pharmaceuticals.
3. Explain the role CMC’s play if the manufacture of pharmaceuticals before and after FDA approval.
4. Describe how cGMP’s are applied to the manufacture of pharmaceuticals before and after FDA approval. Admissions Requirements
Admission to this program is not currently open, but is tentatively planned for Fall 2025. The program has been submitted to the Higher Learning Commission and is pending approval. All Certificate Requirements - 9 Credits Required
Certificate Courses - 9 Credits Required
Notes
Students who return to the university after an interrupted enrollment, not including summer semester, must normally meet the requirements of the curriculum which are in effect at the time of their return, not the requirements which were in effect when they were originally admitted. Credit Variance: Credits required may vary based on course placement, prerequisites, etc. If you have questions, contact your advisor. Graduation Requirements
In order to graduate from Ferris State University, students must meet both University and Programmatic Graduation Requirements. University Graduation Requirements
These are the minimum graduation requirements for an undergraduate certificate at Ferris State University:
• A GPA of 2.00 or higher must be achieved for the courses within the certificate.
• A minimum of 5 credits within the certificate must be earned.
• A minimum of 50 percent of certificate credits must be earned from Ferris State University to meet the Residency requirement. Programmatic Graduation Requirements
These are the additional graduation requirements mandated by the program:
• All requirements as specified in the All Certificate Requirements section must be met. |
Return to: Degree Programs
|
|
|
