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Master of Science (MS) in Quality Assurance/Regulatory Affairs (QA/RA) Established in 1968, the graduate program in QA/RA of Temple University's School of Pharmacy (TUSP) is widely recognized as the oldest and most comprehensive academic curriculum of its kind in the world. Advances in technology during the past decade now enable Temple to deliver the QA/RA program locally, nationally, and internationally. • Offers more than 70 courses taught by over 100 U.S. industry and FDA instructors • Teaches current practices in numerous industry disciplines • Focuses on the critical need to adhere to U.S. and global quality practices and regulatory requirements • Provides a broad understanding of the global pharmaceutical industry • Promotes interactive/hands-on workshops in classes • Covers the entire drug development process • Accepts beginning, mid-career and veteran industry professionals • Offers evening, weekend, and morning classes Course Delivery Temple’s QA/RA courses are offered in various formats: • Traditional classroom instruction at Fort Washington (PA), Frazer (PA), and Tarrytown (NY) • Intensive classroom instruction at pharmaceutical companies • Videoconferencing from Temple U to corporate sites and educational institutions • Quality online learning through an interactive format in real-time Short, non-credit seminars for workforce development are also available. Temple University’s innovative QA/RA graduate program is a hands-on, industry-focused curriculum that prepares students for the global pharmaceutical market. Graduate Program in Quality Assurance/Regulatory Affairs (QA/RA)

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Page 1: TU Pharm qara 1 13

Master of Science (MS) in Quality Assurance/Regulatory Affairs(QA/RA)

Established in 1968, the graduate program in QA/RA of Temple University'sSchool of Pharmacy (TUSP) is widely recognized as the oldest and most comprehensive academic curriculum of its kind in the world. Advances in technology during the past decade now enable Temple to deliver the QA/RA program locally, nationally, and internationally.

• Offers more than 70 courses taught by over 100 U.S. industry and FDA instructors• Teaches current practices in numerous industry disciplines• Focuses on the critical need to adhere to U.S. and global quality practicesand regulatory requirements• Provides a broad understanding of the global pharmaceutical industry• Promotes interactive/hands-on workshops in classes• Covers the entire drug development process• Accepts beginning, mid-career and veteran industry professionals• Offers evening, weekend, and morning classes

Course Delivery

Temple’s QA/RA courses are offered in various formats:

• Traditional classroom instruction at Fort Washington (PA), Frazer (PA),and Tarrytown (NY)• Intensive classroom instruction at pharmaceutical companies• Videoconferencing from Temple U to corporate sites and educational institutions• Quality online learning through an interactive format in real-time

Short, non-credit seminars for workforce development are also available.

Temple University’s

innovative QA/RA

graduate program

is a hands-on,

industry-focused

curriculum that

prepares students

for the global

pharmaceutical

market.

Graduate Program in Quality Assurance/Regulatory Affairs(QA/RA)

Page 2: TU Pharm qara 1 13

Academic Programs

For additional information:Temple University School of Pharmacy

QA/RA Graduate ProgramWendy Lebing, Assistant Dean425 Commerce Drive, Suite 175Fort Washington, PA 19034

www.temple.edu/[email protected]

Master of Science

• Twelve courses (4 required/8 electives)

• Required courses:

Drug Development; Food and Drug Law I; a Good Practices Course; Choice of Quality Audit or Investigational New Drug/New Drug Application(IND/NDA Submissions)

• Eight elective courses from a variety of career tracks:

Drug Discovery • Manufacturing • ComplianceClinical Trials • Global Regulatory AffairsValidation • Quality Assurance • Medical DevicesPharmacovigilance • Generic Drugs

Certificates

Eight certificate programs are offered in the QA/RA graduate program:

• Drug Development

• Global Pharmacovigilance

• Medical Devices

• Clinical Trials

• Biosimilars and Generic Drugs

• Basic Pharmaceutical Development

• GMPs for the 21st Century

• Post Master’s Certificates in Advanced QA and RA

Students can complete a 4 or 5 course certificate and then apply all credits earned towards completion of the MS degree, if they are acceptedfor matriculation. Students focus on a specific aspect of the industry in a condensed period of time, mastering the skills needed to excel ina particular field. Specialized certificates can be created to suit the unique needs of an organization. The program also creates and deliversshort, non-credit seminars for workforce development.

Quality Online LearningQA/RA offers over 30 online courses:

• You can complete most certificates• You can complete the entire MS degree• You can pursue Post-Master's Certificates in Advanced QA or RA

Online classes offer the same academic standards and hands-on learn-ing that make Temple's graduate program in QA/RA the best of itskind. Offering online classes since Fall 2006, the faculty are comfort-able with the technology; the University provides 24-hour technicalsupport; and the QA/RA staff is supportive of students' concerns.

International PartnershipsFor over a decade, the QA/RA graduate program has provided highquality remote learning programs to numerous U.S. corporate sites.Since January 2009, TUSP has delivered courses and certificatesthough videoconferencing and online learning to the NationalUniversity of Singapore, one of the world's top institutions of higherlearning.

The QA/RA program actively seeks global partnerships with institu-tions of higher learning, governments, and corporations. Throughvideoconferencing or online technology, TUSP can:

• provide non-credit courses for workforce development• deliver QA/RA graduate courses or certificate programs• create new certificates to meet workforce needs• deliver the entire QA/RA MS degree