Online Regulatory Affairs Certificates

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Certificate Overview

With this flexible, accelerated online program, you can earn your certificate in Regulatory Affairs from top CSU faculty and experts from the medical device, and pharmaceutical industries. The program was created by Colorado State University's renowned School of Biomedical Engineering in response to industry need.  Courses can also help professionals prepare for the Regulatory Affairs Certification (RAC) Exam by the Regulatory Affairs Professional Society (RAPS).
“The RAC credentials are a professional distinction that denotes commitment to excellence, pursuit of knowledge and career advancement. RAC-credentialed professionals are among the current and rising leaders in the regulatory profession” – Regulatory Affairs Professional Society


Benefits & Outcomes

This training is for those who wish to prepare for work in the medical device, in-vitro diagnostic, tissue, or pharmaceutical industries. Regulatory affairs professionals are qualified to fill a number of specialized roles such as: regulatory affairs manager, pharmaceutical quality assurance manager, quality assurance director, and quality assurance supervisor.
Regulatory affairs managers generally plan, direct, or coordinate production activities of an organization to ensure compliance with regulations.  There are currently approximately 19,000 working regulatory affairs managers in Colorado; this is expected to grow 17% by 2016 to about 22,500 workers. This growth is higher than the national average, where employment opportunities for regulatory affairs managers are expected to grow by about 7.3%. Regulatory affairs manager’s earn about $47 hourly or $99,360 annually on average in Colorado and about $43 hourly or $90,230 annually on average in the U.S. as a whole1.
Admission to Colorado State University is not required to register for these courses.

  • “Career and Education Opportunities for Regulatory Affairs Managers in Colorado” http://www.careeroverview.com/usa/colorado/management/quality-control-and-regulation/regulatory-affairs-manager/

Who Should Attend

Students from engineering or scientific disciplines interested in obtaining employment in the regulatory or quality departments of medical device, tissue or pharmaceutical companies. Students wanting to enhance their hiring potential, can take one or more courses to tailor suit their educational and employment goals.
Industry professionals interested in career advancement opportunities.

Certificate Programs and Curriculum

The majority of the bioscience subsector lies in two areas – medical device and pharmaceuticals.  The Regulatory Affairs Interdisciplinary Program was developed in response to the rising demand from these industries.  The curriculum provides a comprehensive understanding of the central elements of regulatory affairs as it applies to the development and commercialization of these products. The Regulatory Affairs Certification series is comprised of two tracks: Drug & Biologics; and Medical Devices, In-vitro Diagnostics & Tissue Products.  Each track consists of four courses, two required and two from a selection of electives.  Additional coursework is available for those interested in clinical research. The Clinical Trials Management Certification series is comprised of four courses, two required and two from a selection of electives.
Regulatory Course Matrix:
Required Courses:

Regulatory Affairs Certification for the Medical Device, IVD and Tissue Industry
(12 CEU Credits Total – 6 required credits and 6 elective credits):
EGLL 4070 - Medical Device and IVD and Human Tissue Product Discovery to Commercialization (3 CEU)
Regulatory Affairs for the Medical Device Industry (3 CEU)

Regulatory Affairs Certification for the Drug and Biologic Industry Certification
(12 CEU Credits Total – 6 required credits and 6 elective credits):
EGLL 4088 – Pharmaceutical & Biologics Discovery to Commercialization (3 CEU)
Regulatory Affairs for the Pharmaceutical and Biologics Industry (3 CEU)

 

Clinical Trials Management Required Courses
(12 CEU Credits Required– 6 required credits and 6 elective credits):
EGLL 4090- Clinical Trial Training for Principal Investigators and Clinical Research Coordinators (3 CEU)
EGLL 4092 - Clinical Trial Data Management (3 CEU)

Electives:
EGLL 4085 – Nonclinical Studies and Related FDA Regulations (GLP & GCLP) (3 CEU)
EGLL 4080 - cGMP Quality Principles for Pharmaceutical & Biologics Industry
(3 CEU)
EGLL4094 - Quality System (QSR) and ISO 13485 Regulations (3 CEU)
Good Clinical Practice Regulations (GCP) (3 CEU)

What Next?