Increasingly, pharmaceutical companies and medical device companies are developing and marketing combination products that contain both a device and a drug component. Examples include drug- coated stents, prefilled drug delivery devices and antibiotic bone cement.
Companies also market medical and diagnostic devices, through device divisions or subsidiaries, such as in vitro diagnostic instruments and reagents, surgical sponges, and MRI systems (magnetic resonance imaging).
RA professionals from the pharmaceutical or device industries can open job opportunities by studying the similarities and differences in pharmaceutical and medical device regulations. The Medical Device Certificate enables students to receive specific training in the device field, receiving an overview of its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.
The certificate requires completion of five courses:
- Food and Drug Law (5592)
- Regulation of Medical Devices: Submissions (5502)
- Regulation of Medical Devices: Compliance (5496)
- Global Regulation of Medical Devices (5505)
- One of the following electives: Quality Audit (5494) or Computer Validation (5498) or Process Validation (5474) or Pharmaceutical Packaging: Technology & Regulation (5541) or Design Controls for Medical Devices and Combination Products (5503) or Risk Management of Pharmaceutical and Medical Devices (5548) or only those Special Topics course focusing on medical devices (5650).
All courses may be completed online. This certificate allows students to explore QA and RA issues without committing themselves to the entire Master of Science program. The GRE is not required for the Medical Devices Certificate.
All courses taken for the Medical Device Certificate will count toward the MS degree, as long as students are eligible for admission to the RA and QA master's degree and apply to the MS program before completing their third course. Students may obtain only one certificate before completing the MS program, except for Food RA and QA.
Application Information for RAQA Pre-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Pre-Master's Certificates
- Call the RAQA office at 267-468-8560 to speak with a program representative
- Set up an account on our Graduate Application Portal. Once you complete the form, you will receive an email to complete your set up.
- Complete all of the required personal information in the Application Portal.
- Submit all required documents, as listed below.
Once all documents have been received, your application will be submitted to our review panel for evaluation. A representative will be in touch within a week of submitting your application with a timeline for an admissions decision.
Application Requirements for RAQA Pre-Master's Certificates
- A baccalaureate degree, with an undergraduate GPA of 3.0 or higher.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to [click-for-email]. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- 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).
- Resume: Current resume or CV is required.
- Statement of Goals: In approximately 500 to 1,000 words, applicants should state their specific interest in Temple's program, research goals, future career goals, and academic and research achievements.
- Standardized Test Scores: Applicants who earned their baccalaureate degree from an institution where the language of instruction was other than English, with the exception of those who subsequently earned a master's degree at a U.S. institution, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
Questions?
Reach out to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.
Temple University School of Pharmacy
Regulatory Affairs and Quality Assurance
425 Commerce Drive, Suite 175
Fort Washington, PA 19034
267-468-8650
QARA@temple.edu