Pharmaceutical Manufacturing: Process Development and Analysis Certificate

Learn the practices used in all of the critical stages of manufacturing with the Pre-Master’s Certifcate in Pharmaceutical Manufacturing: Process Development and Analysis in Temple’s School of Pharmacy. You’ll have four years to complete five courses that thoroughly cover the key domestic regulations of good manufacturing practice systems. During or after the certificate program, students can apply their credits toward the Master of Science in Regulatory Affairs and Quality Assurance (RAQA). Graduates are able to pursue manufacturing and regulatory careers in the pharmaceutical industry.

Through a hands-on and theoretical approach, you’ll learn how to augment science with regulation. The program will take you through the processes of best practices in the following order

  • control analysis and charting via statistical means,
  • control and monitoring, and
  • unit operations of modern pharmaceutical manufacturing.

After exploring these step-by-step processes, you’ll learn the fundamentals of Six Sigma, a data-driven methodology for eliminating defects. In this overview, you’ll discuss when and if they should be applied.


In order to pursue the Pharmaceutical Manufacturing: Process Development and Analysis Pre-Master’s Certificate, you’re expected to have a strong science background, including familiarity with biology, chemistry and physics as well as a basic understanding of pharmaceutical manufacturing processes. You should have a Bachelor of Science in Biology, Chemistry, Engineering or Pharmacy from an accredited institution of higher learning.

Classes & Curriculum

In the recommended sequence, courses include

  • Regulatory Sciences: Managing the Guidelines for Quality;
  • Unit Operations;   
  • Process Analytical Technology or Microbiological Concepts in Pharmaceutical Manufacturing;
  • Statistical Design of Experiments; and
  • Process Monitoring.

Learn more about Pharmaceutical Manufacturing: Process Development and Analysis Pre-Master’s Certificate courses (PDF).

Related Graduate Degrees

Related Graduate Certificates

Career Opportunities 

Alumni and current students of the Regulatory Affairs and Quality Assurance graduate program can join the job postings listserv to gain access to current career opportunities.

Career Night
Regulatory Affairs and Quality Assurance hosts an annual career night for students to meet with representatives from at least a dozen actively hiring companies. The evening features presentations on topics for breaking into the industry and gaining employment, such as interviewing tips and resume writing.

Students are also encouraged to speak with Regulatory Affairs and Quality Assurance faculty about their professional goals and ambitions.

Delivery Method

The Master of Science in Global Clinical and Pharmacovigilance, Master of Science Non-Thesis in Pharmaceutical Sciences, Master of Science in Regulatory Affairs and Quality Assurance, and most certificates can be completed in-person at Temple’s Fort Washington location or online. The Regulatory Affairs and Quality Assurance graduate program offers more than 60 elective courses online.

Online courses in the RAQA program are offered in real time. You’ll participate in classes each week at a specific time, watching live lectures given by your instructor through interactive platforms. This format enables you to interact with other professionals across the country and world.

Tuition & Fees

In keeping with Temple’s commitment to access and affordability, this Graduate Certificate offers a competitive level of tuition with multiple opportunities for financial support.

Tuition rates are set annually by the university and are affected by multiple factors, including program degree level (undergraduate or graduate), course load (full- or part-time), in-state or out-of-state residency, and more. These tuition costs apply to the 2019–2020 academic year.

Pennsylvania resident: $1,072.00 per credit
Out-of-state: $1,358.00 per credit

Learn more about our tuition and fees.


Additional Program Information

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