2012 - 2013 Site Archive



Graduate Bulletin

Quality Assurance/Regulatory Affairs, M.S.


Admission Requirements and Deadlines
Application Deadline:

Fall: August 1; December 15 international

Spring: December 15; August 1 international

Applications are processed throughout the year with no specific deadline. However, the entire application packet must be received by the QA/RA Graduate Studies Office before it is reviewed by the Admissions Committee. Students are responsible for making sure that all materials have been received.

APPLY ONLINE to this graduate program.

Letters of Reference:

Number Required: 2

From Whom: 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 QA/RA graduate program.

Coursework Required for Admission Consideration:

No specific coursework is required.

Bachelor's Degree in Discipline/Related Discipline:

A B.S. degree in Biology, Biochemistry, Chemistry, Physics, or a health-related discipline is required.

Statement of Goals:

Students should describe their experience in the pharmaceutical or related industries, indicating how the QA/RA program will help them achieve their career objectives.

Standardized Test Scores:

The GRE/GMAT is no longer required.

Minimum TOEFL score needed to be accepted: 100 iBT or 600 PBT. The TOEFL must have been taken within the past two years.


A resume is required.

Transfer Credit:

Students may transfer a maximum of 6 credits into the M.S. program. These credits must be similar or identical to courses offered in Temple's QA/RA program. In addition, the student must request the transfer credits at the time of application to the M.S. program, providing copies of course syllabi. The maximum number of credits a student may transfer is 6.

Program Requirements
General Program Requirements:

Number of Didactic Credits Required Beyond the Baccalaureate: 36

Required Courses:

Drug Development

Food and Drug Law I

Good Practices (either GCPs, GLPs or GMPs)

Quality Audit or IND/NDA Submissions

The remaining 8 courses are electives. After the four required courses, students may either concentrate in QA or RA electives, or students may select courses from both disciplines to broaden their portfolio.

Internship: No internship is required.

Language Examination: No language examination is required.

Culminating Events:

This program has no culminating events.

Program Contact Information:


Department Information:

QA/RA Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2713


Department Contacts:


Wendy Lebing, MALD, M.S.


Program Coordinator:

Wendy Lebing, MALD, M.S.


Graduate Chairperson:

Daniel Canney, Ph.D.



Wendy Lebing, MALD, M.S.


About the Program

Since 1968, Temple's QA/RA program has played a significant role in training pharmaceutical company personnel in regulations and quality principles and practices. Its courses meet 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:

Fort Washington

The M.S. is offered in its entirety on evenings and weekends at Fort Washington.

Full-Time/Part-Time Status:

Students are able to complete the degree program through classes offered after 4:30 p.m. Students are also able to complete the degree program on a part-time basis (8 credit hours or less per semester).

Continuous Enrollment:

Because the QA/RA student is typically a working professional, continuous enrollment in the program is not required. Thus, students do not need to be enrolled each semester (Fall and Spring) to maintain current status and are exempt from filing a Leave of Absence form when opting to take a semester off.

Department Information:

QA/RA Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2713


Interdisciplinary Study:

The program fosters interdisciplinary study with the pharmaceutical sciences and technology.


Each year the program sponsors a major conference with the pharmaceutical industry and the U.S. FDA, focusing on current regulatory and quality issues.

Study Abroad:



Established in 1968, Temple's QA/RA master's degree is widely recognized as the oldest, most comprehensive, and most respected academic program of its type in the world.


Not applicable.

Areas of Specialization:

This is a non-thesis M.S. program. Faculty members are specialists in many areas, such as Quality Assurance; Regulatory Affairs; auditing; clinical trial management and operations; global regulation; IND/NDA submissions; manufacturing; pharmaceutical, food, and device law; pharmaceutical labeling and advertising; and validation.

Job Placement:

Students find positions in all areas of the pharmaceutical industry, including big PhRMA and generic companies, clinical research organizations, medical devices and packaging, and biotechnology. Government agencies, including the FDA, and healthcare providers are also represented.


Not applicable.

Non-Matriculated Student Policy:

Students may complete a maximum of 9 s.h. before they must formally apply for admission. Before taking any electives, new students are strongly encouraged to take the courses in Drug Development and Food and Drug Law.

Financing Opportunities

Students in the QA/RA program are generally working professionals. Therefore, funding for assistantships and academic internships is limited.

Updated 11.6.12