Good Manufacturing Practices for the 21st Century Certificate
Learn the practices used in all of the critical stages of manufacturing with the Pre-Master’s Certifcate in Good Manufacturing Practices for the 21st Century 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 Good Manufacturing Practices for the 21st Century 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.
Related Graduate Degrees
- Global Clinical and Pharmacovigilance MS
- Pharmaceutical and Regulatory Sciences MS [ed. note: link to come]
- Pharmaceutical Sciences MS
- Pharmaceutical Sciences PhD
- Regulatory Affairs and Quality Assurance MS
Related Graduate Certificates
- Advanced Regulatory Affairs and Quality Assurance Certificate
- Basic Pharmaceutical Development Certificate
- Biopharmaceutical Manufacturing and Regulatory Affairs (Biotechnology) Certificate
- Biosimilars and Generic Drugs Certificate
- Clinical Trial Management Certificate
- Drug Development Certificate
- Food Regulatory Affairs and Quality Assurance Certificate
- Global Pharmacovigilance: Benefit-Risk Assessment Certificate
- Labeling, Advertising, and Promotions Certificate
- Medical Devices Certificate
- Sterile Process Manufacturing Certificate