The Post-Master’s Certificate in Pharmaceutical Manufacturing: Process Development and Analysis (formerly GMPs for the 21st Century) teaches the concepts of continuous manufacturing quality in regulated industry, such as 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).
Through hands-on and theoretical approaches, students will expand their knowledge of science and engineering principles with information about current regulations. This certificate covers best practices for process development and analysis best practices.
Three required courses are:
- Unit Operations (5622) (must be taken prior to 5629)
- Process Monitoring (5629)
- Statistical Design of Experiments (DOE) (5627)
Students who completed an MS in RAQA from Temple must also choose one elective course from the following list. Students who did not earn their MS in RAQA from Temple must take two elective courses.
- Process Analytical Technology (PAT) (5625)
- Microbiological Concepts in Pharmaceutical Manufacturing (5512)
- Risk Management for Pharmaceuticals and Medical Devices (5548)
If a graduate with the MS in RAQA has completed all of the electives mentioned above as part of the master’s degree, the RAQA Office will provide additional options.
The certificate may be earned on its own or on the way to the MS in RAQA. To earn the certificate, courses must be successfully completed within a three year period with an overall B (3.0) average.
Application Information for RAQA Post-Master's Certificates
Applying is straight-forward and convenient, with Temple's Online Graduate Application Portal.
Application Process for RAQA Post-Master's Certificates
- Contact the RAQA office 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 Post-Master's Certificates
- A master’s degree in a pharmacy-related field and a bachelor of science degree in biology, chemistry, engineering, pharmacy, physics or related fields
- 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).
- You must apply before starting the program on the Graduate Application Portal.
- Transcripts: Transcripts from all post-secondary institutions attended may be sent electronically to qara@temple.edu. Alternately, unopened official transcripts bearing the school's seal must be sent directly from the Registrar at each institution to the School of Pharmacy.
- 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. It should also indicate which courses you would like to pursue, cite your industry experience, and include at least two alternate courses to allow for greater scheduling flexibility.
- Standardized Test Scores: Applicants who earned their master's degree from an institution where the language of instruction was other than English, must report scores for a standardized test of English that meet these minimums:
- TOEFL iBT: 85
- Some certificates require proof of work experience in RAQA or Biosimilar Manufacturing. Please contact the RAQA Program Office for specific details.
Questions?
Contact our office directly to learn more about this program, discuss admissions criteria, or schedule a time to meet with a faculty member.