Post-Master's Certificate: Medical Device

SCHOOL OF PHARMACY

About the Certificate

The post-master's certificate in Medical Device is designed for those who hold an MS in Regulatory Affairs and Quality Assurance and want to keep current with industry issues and meet regulatory requirements for training. The certificate program is also open to professionals with other master's or doctoral degrees.

The U.S. Food and Drug Administration (FDA) regulation of medical devices has the same objective as its regulation of drugs: protecting public health by ensuring a balance of risk vs. benefit for marketed products. Some high-risk medical devices, such as sutures, contact lenses and antibiotic sensitivity disks, were regulated as drugs before legislation was passed in 1976 extending the FDA’s regulatory authority over devices. Because medical devices are highly variable in complexity and technology, a more flexible approach to regulation has evolved to meet this variability than has evolved for drugs.

Coursework for the Medical Device post-master's certificate focuses on the domestic and global regulations governing the medical device field. Many pharmaceutical companies have separate device divisions or entire subsidiaries that focus on marketing medical and diagnostic devices, such as diagnostic instruments and kits, surgical sponges, and drug delivery devices, which range from syringes to transdermal patches. Regulatory affairs professionals pursuing this certificate deepen their understanding of the device field by exploring the similarities and differences in pharmaceutical and device regulations. The certificate reviews key aspects of the medical device industry: regulation, compliance and submissions in the domestic and global realms. Instructors are experts from the medical device sector who conduct highly interactive classes with hands-on workshops, enabling students to apply their knowledge immediately to the workplace.

Time Limit for Certificate Completion: 4 years

Campus Location: Fort Washington and Online

Full-Time/Part-Time Status: The certificate may be completed on a part-time basis. NOTE: International students may not be eligible to apply for a student visa based on admission to the certificate program. Please contact the School of Pharmacy's program coordinator for more information.

Non-Matriculated Student Policy: Non-matriculated students may take up to 9 credits of coursework before applying to the certificate program.

Admission Requirements and Deadlines

Application Deadline:
Fall and Spring admissions are on a rolling basis. Interested students should contact the School of Pharmacy for permission to enroll in coursework.

APPLY HERE to the post-master's certificate program.

Master's Degree in Discipline/Related Discipline: Applicants must hold a master's degree in a Pharmacy-related field, including but not limited to an MS in Regulatory Affairs and Quality Assurance. Graduates of Temple University's RAQA program take certificate coursework to keep current with industry issues and meet regulatory requirements for training. Applicants with an advanced science degree from an accredited institution of higher learning other than Temple University must have worked in the pharmaceutical industry for a minimum of three years.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a bachelor's degree from an accredited institution. While no specific major is required, most applicants should have a background in biological sciences, engineering, healthcare, natural sciences or related disciplines.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 15

Required Courses:

Core Courses
QARA 5496Regulation of Medical Devices: Compliance3
QARA 5502Regulation of Medical Devices: Submissions3
QARA 5505Global Regulation of Medical Devices3
QARA 5592Food and Drug Law 13
Elective
Select one from the following:3
Process Validation
Quality Audit
Computerized System Validation
Design Controls for Medical Devices and Combination Products
Advanced Audit Workshop of Quality Systems
Pharmaceutical Packaging: Technology and Regulation
Risk Management of Pharmaceutical and Medical Devices
Total Credit Hours15

GPA Required to be Awarded the Certificate: 3.0 minimum

Contacts

Certificate Program Web Address:

https://pharmacy.temple.edu/raqa/certificate-programs/post-masters-certificates/medical-devices

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

qara@temple.edu

267-468-8560

Mailing Address for Application Materials:

Temple University

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728

Department Contacts:

Admissions:

Wendy Lebing, MALD, MS

Program Coordinator

qara@temple.edu

267-468-8560