Program Overview

Regulatory Affairs and Quality Assurance MS

The Master of Science in Regulatory Affairs and Quality Assurance is a program offered by Temple University's School of Pharmacy.

About the Program

Since its establishment in 1968, Temple's Regulatory Affairs and Quality Assurance (RAQA) program has played a significant role in training pharmaceutical company personnel in regulations and quality principles and practices. Coursework meets the career requirements of professionals in the pharmaceutical and related industries. The program provides students with a broad knowledge of the industry, fostering their professional development and preparing them for supervisory and managerial positions.

• Time Limit for Degree Completion: 5 years
• Campus Location: Online and Fort Washington
• Full-Time/Part-Time Status: The degree program can be completed on a full- or part-time basis. The MS is offered in its entirety on evenings and weekends at Fort Washington.
• Interdisciplinary Study: The program fosters interdisciplinary study between the pharmaceutical sciences and technology.
• Affiliation(s): Each year the program sponsors a major conference with the pharmaceutical industry and the U.S. Food and Drug Administration (FDA), focusing on current regulatory and quality issues.
• Ranking: Temple's RAQA master's degree is widely recognized as the oldest, most comprehensive, and most respected academic program of its type in the world.
• Areas of Specialization: This is a non-thesis MS program. Faculty members are specialists in many areas, such as auditing; clinical trial management and operations; global regulation; IND/NDA submissions; manufacturing; pharmaceutical, food and device law; pharmaceutical labeling and advertising; quality assurance; regulatory affairs; and validation.
• Job Prospects: Students find positions in all areas of the pharmaceutical industry, including big Pharmaceutical Research and Manufacturers of America (PhRMA) and generic companies, biotechnology, clinical research organizations, and medical devices and packaging. Employment is also found with government agencies, including the FDA, and healthcare providers.

Admission Requirements and Deadlines

• Application Deadline:
  • March 1; December 15 international
  • November 1; September 1 international
  • Summer I: March 1; January 15 international
• Letters of Reference: 2
  • One letter should be obtained from the candidate's direct supervisor, indicating that the supervisor is aware of and supports the candidate's involvement in Temple's RAQA graduate program.
• Bachelor's Degree in Discipline/Related Discipline: A BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline is required.
• Applicants who earned a degree at a non-U.S. institution must submit an equivalency evaluation of their transcript(s) through a third-party provider, either World Education Services (WES) or Educational Credential Evaluators (ECE).
• Statement of Goals: Describe your experience in the pharmaceutical or related industries, indicating how the RAQA MS program will help you achieve your career objectives.
• Standardized Test Scores:
  • TOEFL iBT: 85
  • IELTS Academic: 6.5
  • PTE Academic: 58
• Resume: Current resume or CV required.
• Transfer Credit: Students may transfer a maximum of 6 credits into the MS program. These credits must be similar or identical to courses offered in Temple's RAQA program.

Program Requirements

• General Program Requirements:
  • Number of Credits Required Beyond the Baccalaureate: 36
• Required Courses: | Course List Code | Title | Credit Hours | | --- | --- | --- | | QARA 5459 | Drug Development | 3 | | QARA 5494 | Quality Audit | 3 | | or QARA 5495 | Investigational New Drug/New Drug Application Submissions | 3 | | QARA 5592 | Food and Drug Law | 3 |
  • Good Practices Course: Select one from the following:
    • QARA 5476 | Good Laboratory Practices | 3
    • QARA 5477 | Good Manufacturing Practices | 3
    • QARA 5479 | Advanced Good Manufacturing Practices - Defining "c" | 3
    • QARA 5536 | Good Clinical Practices | 3
  • Electives: 24
  • Total Credit Hours: 36
• Culminating Event: Successful completion of coursework is required to earn the MS in Regulatory Affairs and Quality Assurance.