Graduate Certificate: Pharmaceutical Manufacturing: Process Development and Analysis


About the Certificate

The graduate certificate in Pharmaceutical Manufacturing: Process Development and Analysis is designed to enhance students' understanding of the science and regulations involved in pharmaceutical manufacturing processes. Through coursework, students learn how to set standards for increasing product quality, improve plant efficiency, lower production costs, and meet current domestic and global compliance requirements. The curriculum also reflects the culture of meeting continuous manufacturing quality, such as the Food and Drug Administration's Quality Metric Guidance document and its focus on data integrity, change control, quality risk management, Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ).

Time Limit for Certificate Completion: 3 years

Campus Location: Online and Fort Washington

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-baccalaureate certificate program.

Bachelor's Degree in Discipline/Related Discipline: Applicants must hold a BS degree in Biochemistry, Biology, Chemistry, Engineering, Pharmacy, Physics or related discipline. They must also have a basic knowledge of pharmaceutical manufacturing processes.

Certificate Requirements

Number of Credits Required to Complete the Certificate: 12

Required Courses:

Core Courses 1
QARA 5622Unit Operations3
QARA 5627Statistical Design of Experiments (DOE)3
QARA 5629Process Monitoring3
Select one from the following:
Microbiological Concepts in Pharmaceutical Manufacturing
Risk Management of Pharmaceutical and Medical Devices
Process Analytical Technology (PAT)
Total Credit Hours12

GPA Required to be Awarded the Certificate: 3.0 minimum


Certificate Program Web Address:

Department Information:

Regulatory Affairs and Quality Assurance Graduate Program

425 Commerce Drive, Suite 175

Fort Washington, PA 19034-2728


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:


Wendy Lebing, MALD, MS

Assistant Dean