Biomedical Quality Systems Advanced Certificate

(Academic Plan Code: 771492ACTE)

Offered in partnership with the Center for Regulatory Science in the College of Sciences and SDSU Global Campus

Students in the Advanced Certificate in Biomedical Quality Systems are presented with an international view of the biomedical industry and Safe Medical Devices Act from a quality perspective. Roles and responsibilities of a typical quality assurance (QA) department are reviewed for biopharmaceutical, medical device, and pharmaceutical industries. Also covered are practical skills, approaches, and solutions related to auditing, change control, compliance, documentation, laboratory, material, and production control issues. Students build a foundational and practical knowledge in quality systems and biomedical regulations related to major elements and principles of international regulations governing control of data, documents, information, and records associated with biomedical products.

Requires 12 Units

Certificate courses may be applied to the Master of Science degree in regulatory affairs as elective courses.

For more information, go to http://regsci.sdsu.edu or call 619-594-6030.

The certificate requires 12 units to include

BQS 601 - Biomedical Quality Systems Units: 3
BQS 603 - Foundational Quality Systems Units: 3
BQS 730 - Good Manufacturing, Laboratory, and Clinical Practices Units: 3
BQS 745 - Document Control Quality System Units: 3

Admission to Graduate Study

All students must satisfy the general admission and examination requirements for admission to the university with classified graduate standing, as described in Admission and Registration . In addition, the applicant must satisfy the following requirements before being considered for admission to classified graduate standing by the admissions review committee of the department. Students applying for admission should electronically submit the university application available at http://www.calstate.edu/apply along with the application fee.

All applicants must submit admissions materials separately to SDSU Graduate Admissions and to the Regulatory Affairs office.

Graduate Admissions

The following materials should be submitted as a complete package directly to:

Graduate Admissions
Enrollment Services
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-7416

Official transcripts (in sealed envelopes) from all postsecondary institutions attended;
Students who attended SDSU need only submit transcripts for work completed since last attendance;
Students with international coursework must submit both the official transcript and proof of degree. If documents are in a language other than English, they must be accompanied by a certified English translation.

Regulatory Affairs

The following materials should be mailed or delivered to:

Biomedical Quality Systems Certificate
Director of Regulatory Affairs Programs
San Diego State University
5500 Campanile Drive
San Diego, CA 92182-1010

Resume or curriculum vita listing employment or volunteer experience relevant to the proposed new degree major program;
One set of official transcripts (in addition to those sent to Graduate Admissions).