Available at Pre- and Post-Master’s Levels

Pre-Master’s Certificate in Pharmaceutical Manufacturing:  Process Development and Analysis

This certificate provides a theoretical and hands-on approach to practices used in the critical stages of manufacturing, thoroughly covering the key domestic regulations of GMP systems. It reflects the current culture of continous manufacturing quality, reflecting FDA's Quality Metric Guidance document and its focus on data integrity, change contyrol, quality risk management, and IQ, OQ, and PQ (Installation Qualifications, Operational Qualifications, and Performance Qualifications).  Students pursuing this Certificate arre expected to hae 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 requires completion of FOUR courses.  Three are required:

• Unit Operations (5622)
• Statistical Design of Experiments (DOE) (5627)
• Process Monitoring (5629)

Students then select one elective from:

• Process Analytical Technology (PAT) (5625)
• Microbiological Concepts in Pharmaceutical Manufacturing (5512)
• Risk Management for Pharmaceutical and Medical Devices (5548)

Students have four years to complete the Certificate and must maintain and overall B average. Transfer credits are not accepted towards the Certificate.

Brochure
Application Form
Notice of Completion

Post-Master’s Advanced Certificate in Pharmaaceutical Manufacturing:  Process Development and Analysis

Students who have received the M.S. are eligible to complete the Post-Master’s Certificate in Pharmaceutical Manufacturing:  Process Development and Analysis. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate. Students need to take four additional courses beyond the M.S. to receive the additional Certificate in Pharmaceutical Manufacturing:  Process Development and Analysis. Only the following courses may be taken towards completion of this program:

• Unit Operations (5622) (required)
• Process Analytical Technology (PAT) (5625)
• Statistical Design of Experiments (DOE) (5627) (required)
• Microbiological Concepts in Pharmaceutical Manufacturing (5512)
• Risk Management for Pharmaceuticals and Medical Devices (5548)
• Pharmaceutical Quality Management Systems (5574)*
• Process Monitoring (5629) (required)
• Regulatory Sciences:  Managing the Guidelines for Quality (5575)*
• Advanced Good Manufacturing Practices – defining “c” (5479)*

Brochure
Application
Post-M.S. Notice of Completion

This certificate is open to students who received their master's degrees from other schools.

*This course only counts toward the Certificate in Pharmaceutical Manufacturing:  Process Development and Analysis only if the student already has an M.S. in QA/RA.