Quality Assurance and Regulatory Affairs

Master of Science Degree

The Master of Science Degree in Quality Assurance and Regulatory Affairs at Farmingdale State College (FSC) is designed to graduate qualified professionals capable of taking leadership roles in the Quality Assurance and Regulatory Affairs systems that regulate the pharmaceutical, biologics and medical device industries in the country. This program will provide an exceptional and affordable opportunity for advanced study in the critical field of Quality Assurance/Regulatory Affairs to qualified graduates of baccalaureate programs in Bioscience, Biology, Chemistry and related fields. The multi-disciplinary program builds on the strengths of the faculty in the Bioscience, Mathematics, Professional Communications and Business Departments. Drawing on these strengths and addressing the industrial needs in the region, the program consists of a foundation of course work concluding with a capstone project or internship placement with a company or organization in this field. This degree can be earned with part-time or full-time study.  Courses are generally offered in the evening, weekends or online to provide access for working professionals.

Quality Assurance and Regulatory Affairs Program Outcomes:

Graduates will be able to:

• Interpret and apply the requirements of the Food Drug and Cosmetic Act as implemented through CFR 21 sections that apply to drugs, biologics, cosmetic, food and devices
• Understand, analyze and apply the regulations governing the product development process, from discovery to marketing, including interactions with FDA and other regulatory agencies
• Define, validate, review and document procedures in a manufacturing facility that meets the standards of Good Manufacturing Practices
• Generate a Standard Operating Procedure for a manufacturing process that includes all of the elements necessary to ensure that the resulting product meets all quality control criteria
• Design, conduct, and document a nonclinical safety study that meets the standards of Good Laboratory Practice
• Evaluate and revise, if necessary, the design, conduct, monitoring, analysis and reporting of a clinical trial to ensure that it meets the standards of Good Clinical Practice
• Collect, organize, and analyze data that are needed to support official reports to the FDA as needed to demonstrate compliance with CFR standards
• Prepare and support reports to the FDA at a professional level necessary to respond to inquiries about various products and processes

Admission to Farmingdale State College - State University of New York is based on the qualifications of the applicant without regard to age, sex, marital or military status, race, color, creed, religion, national origin, disability or sexual orientation.