The Pharmaceutical Manufacturing: Process Development and Analysis Certificate provides a theoretical and hands-on approach to practices used in the critical stages of manufacturing, thoroughly covering key domestic regulations of GMP systems. It reflects the current culture of continuous manufacturing quality, reflecting FDA's Quality Metric Guidance document and its focus on data integrity, change control, quality risk management, and IQ, OQ, and PQ (Installation Qualifications, Operational Qualifications, and Performance Qualifications).
Students pursuing the Pharmaceutical Manufacturing: Process Development and Analysis Certificate are expected to have a strong science background, including a BS in pharmacy, chemistry, biology, or engineering from an accredited institution of higher learning. In addition, they should have a basic understanding of pharmaceutical manufacturing processes.
The Certificate consists of four courses. Required courses are:
- Unit Operations (Pharmaceutics 5622)
- Process Monitoring (5629)
- Statistical Design of Experiments (DOE) (5627)
And one elective from the following:
- Process Analytical Technology (PAT) (5625)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Risk Management for Pharmaceutical and Medical Devices (5548)
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 Pharmaceutical Manufacturing: Process Development and Analysis Certificate.
All courses taken for the 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