GMPs for the 21st Century

Available at Pre- and Post-Master’s Levels

Pre-Master’s Certificate in GMPs for the 21st Century

This certificate provides a sound theoretical and hands-on approach to practices used in all of the critical stages of manufacturing, thoroughly covering the key domestic regulations of GMP systems. The overall goals of this program is for participants to enhance their scientific understanding of the manufacturing processes, set standards for increasing product quality, improve plant efficiency, lower production costs, and meet the new compliance requirements (both domestic and global). It challenges students to combine science with the regulatory requirements now demanded of GMPs.

The required courses include:

  • Regulatory Sciences: Managing the Guidelines for Quality (5575)
  • Unit Operations (5622)
  • Process Analytical Technology (PAT) (5625)
  • Statistical Design of Experiments (DOE) (5627)
  • Process Monitoring (5629)

Students have four years to complete the Certificate in GMPs for the 21st Century and must maintain and overall B average.

Brochure
Application Form
Notice of Completion

Post-Master’s Advanced Certificate in GMPs for the 21st Century

Students who have received the M.S. are eligible to complete the Post-Master’s Certificate in GMPs for the 21st Century. Courses taken for the completion of the M.S. degree will not be counted towards the Post-Master’s Certificate in GMPs for the 21st Century. Students need to take five additional courses beyond the M.S. to receive the additional certificate in GMPs for the 21st Century. Only the following courses may be taken towards completion of this program:

  • Regulatory Sciences: Managing the Guidelines for Quality (5575)
  • Unit Operations (5622)
  • Process Analytical Technology (PAT) (5625)
  • Statistical Design of Experiments (DOE) (5627)
  • Pharmaceutical Quality Management Systems (5574)*
  • Process Monitoring (5629)
  • 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 GMPs for the 21st Century only if the student already has an M.S. in QA/RA.