Program Overview

Regulatory Affairs & Quality Assurance

The Regulatory Affairs and Quality Assurance (RAQA) program at Temple University offers a range of certificates, degrees, and courses in the field of regulatory affairs and quality assurance.

Certificate Programs

The RAQA program offers several certificate programs, including:

• Pre-Master's Certificates
  • Sterile Process Manufacturing Certificate
  • Basic Pharmaceutical Development Certificate
  • Biologics and Biosimilars Manufacturing Certificate
  • Biologics and Biosimilars: Regulatory Aspects Certificate
  • Biopharmaceutical Manufacturing and Regulatory Affairs Certificate
  • Clinical Trial Management Certificate
  • Drug Development Certificate
  • Food RA and QA Certificate
  • Generic Drug Certificate
  • Global Pharmacovigilance: Benefit-Risk Management Certificate
  • Labeling, Advertising, and Promotions Certificate
  • Medical Devices Certificate
  • Pharmaceutical Manufacturing: Process Development and Analysis Certificate
  • Validation Science Certificate
• Post-Master's Certificates

Degree Programs

The RAQA program offers several degree programs, including:

• Master of Science in Regulatory Affairs and Quality Assurance
• Master of Science in Pharmaceutical Regulatory Sciences
• Master of Science in Global Clinical and Pharmacovigilance Regulations

Courses

The RAQA program offers a range of courses, including:

• Microbiological Concepts in Pharmaceutical Manufacturing
• Production of Sterile Products
• Sterilization Processes
• Statistical Quality Control
• Development of Sterile Products
• Vaccines: RA and QA Issues

Application Information

To apply to the RAQA program, students must submit the following:

• A baccalaureate degree with an undergraduate GPA of 3.0 or higher
• Transcripts from all post-secondary institutions attended
• A current resume or CV
• A statement of goals (approximately 500-1000 words)
• Standardized test scores (if applicable)

Tuition and Financial Aid

Information on tuition and financial aid is available through the Temple University School of Pharmacy.

Student Policies and Forms

The RAQA program has several policies and forms in place, including:

• Academic honesty policy
• Drop/add policy
• Emergency closings policy
• Forms for RAQA graduate programs
• Graduation procedures
• International students policy
• Matriculation fees
• News and updates
• Prerequisites
• Proctored exams policy
• Recording classes policy
• Reviewing a grade policy
• TUid (OwlCard) policy
• Tax credits for education
• Transfer credits policy
• Tuition deposit policy

Sterile Process Manufacturing Certificate

The Sterile Process Manufacturing Certificate is a four-course certificate that explores the routes and types of sterile product administration, manufacturing and facility requirements, and validation and compliance specifications. The certificate is available entirely online and requires students to complete two required courses and two elective courses.

Fundamentals of Sterile Process Manufacturing

Sterile products must be manufactured in a manner that eliminates or minimizes microbial contamination. The Fundamentals of Sterile Process Manufacturing course covers the technical and regulatory aspects of sterilization processes, including thermal, gaseous, radiation, filtration, and aseptic processing methods.

Application Process

The application process for the RAQA program involves submitting an application through the Temple University Online Graduate Application Portal, which includes providing personal information, transcripts, and other required documents. Once all documents have been received, the application will be submitted to the review panel for evaluation.