Available at Pre- and Post-Master’s Levels
Pre-Master’s Certificate in Medical Devices
Increasingly, pharmaceutical companies and medical device companies develop combination products that contain both a device and a drug component (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 magnetic resonance imaging [MRI] systems).
RA professionals from either the pharmaceutical or medical device industries can deepen their understanding by studying the similarities and differences in pharmaceutical and medical device regulations.
The Medical Device Certificate enables students to receive specific training in the medical device field, familiarizing them with its domestic and global regulations. All courses provide hands-on application of regulations and quality practices.
The certificate requires the completion of five courses:
- Food and Drug Law (5592)
- Regulation of Medical Devices: Submissions (5502)
- Regulation of Medical Devices: Compliance (5496)
- Global Medical Device Regulation (5505)
- One of the following pharmaceutical RAQA electives: Quality Audit (5494) or Computer Validation (5498) or Process Validation (5474) or Pharmaceutical Packaging: Technology & Regulation (5541) or Risk Management of Pharmaceutical and Medical Devices (5548) or any Special Topics course focusing on medical devices.
Students have five years to complete the Medical Device Certificate and must maintain an overall B average.
Post-Master’s Certificate in Medical Devices
Students who have received the M.S. in RAQA from Temple are eligible to complete the Post-Master’s Certificate in Medical Devices. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate in Medical Devices. Students need to take four additional courses beyond the M.S. to receive the additional certificate in Medical Devices. Three of the courses taken must be Pharmaceutics 5496, 5502 and 5505. If one (or more) of those courses were already completed while the student was pursuing the M.S., the student may substitute other courses from the list of accepted courses. This certificate is also open to students who received their master's degrees from other schools; however, those students must complete Food and Drug Law (5592) before taking any of the medical device courses; thus, their certificate will consist of five courses. For additional information, click here.