About QA/RA and The Temple School of Pharmacy

Thank you for your interest in the Quality Assurance/Regulatory Affairs graduate program of Temple Universityís School of Pharmacy. 

Our program is the most comprehensive academic curriculum of its kind, featuring advanced courses in the quality principles and regulatory issues affecting todayís pharmaceutical industry.  Our program fulfills regulatory requirements for training and also helps individuals develop critical thinking skills in regulatory and quality issues for career advancement.

Experts from industry and FDA teach our classes.  All have considerable experience in legal, regulatory, quality, and compliance activities in a variety of companies, fields, and disciplines. A major reason the program has become so successful is the strength of our faculty.  They share their tremendous hands-on experience with our students in small classes, encouraging insightful dialogues about industry practices and current regulations.

The majority of the students are from the pharmaceutical industry, representing nearly every major corporation across the nation. The remaining students are from related firms such as pharmaceutical support, food and chemical companies, and the healthcare arena. Others work for key regulatory agencies. The experience and knowledge of the students vary considerably. Some are new to the industry while others have been there for decades. The synergy of newcomers and veterans affords students the benefit of repeated networking opportunities.

Temple University was the first institution of higher learning to develop a masterís program in Quality Assurance and Regulatory Affairs in 1968.  With so many decades of experience, we offer the largest number of courses in these disciplines and continue to add courses to incorporate the latest trends.

The curriculum enables students to gain a thorough grounding in the drug development process by studying domestic and international laws and regulations combined with quality principles and practices.  The core courses (Drug Development, Food and Drug Law, Good Practices, and Quality Audit or IND/NDA Submissions) provide students with a strong foundation in the fundamentals, while elective courses (such as Global CMC and the Regulatory Dossier, High Purity Water Systems, or Regulatory SciencesManaging the Guidelines for Quality) enable students to delve deeper into specific aspects of the industry.  There are specific certificates that enable students to specialize in a given area, such as Clinical Trial Management, Medical Devices, or Biopharmaceuticals and Generic Drugs.   Conversely there are electives in the pharmaceutical sciences (such as Biotechnology), which broaden the technical knowledge of students aspiring to careers in the Regulatory Sciences. Those interested in manufacturing will also find numerous courses in all aspects of quality, including the new certificate in GMPs for the 21st Century.

Temple University continues to be the pioneer in this educational field.  The School of Pharmacy was the first institution to develop certificate programs in Drug Development and Clinical Trials.  It was also the first school to create a certificate in Medical Devices.  The broad curriculum gives students many choices.  Students may: 

        enhance their knowledge of the pharmaceutical industry by taking one course or more;

        complete a certificate in a specific area, so they have credentials;

        pursue the entire MS, either mixing QA and RA courses or targeting their chosen electives in a specific aspect of the industry (Quality or Regulatory or clinical trials or pharmaceutical sciences, etc).

Temple allows students to explore the program by taking a maximum of three courses before formally matriculating into the Master of Science.  Students are also welcome to earn one of our certificates (Drug Development, Clinical Trial Management, Medical Devices, Basic Pharmaceutical Development, GMPs for the 21st Century, or Biopharmaceuticals and Generic Drugs) on their way to the masterís.

We offer information sessions at our Open Houses each semester, or are happy to visit your pharmaceutical site to speak about our unique program.  Contact qara@temple.edu for more information.

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