About the Certificate
The post-master's certificate in Advanced Regulatory Affairs and Quality Assurance is designed to allow individuals holding a master's degree in Regulatory Affairs and Quality Assurance (RAQA) to pursue advanced coursework from a broad array of topics and receive formal recognition for their work. The certificate program is also open to those holding an advanced degree in the sciences who have worked extensively in the pharmaceutical industry and seek a cadre of advanced courses in RA or QA to be compliant with Food and Drug Administration regulations on training records.
Time Limit for Certificate Completion: 3 years
Campus Location: Online and Fort Washington
Full-Time/Part-Time Status: The post-master's 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-master's certificate program.
Master's Degree in Discipline/Related Discipline: Applicants completing the program to earn the post-master's certificate must hold a master's degree in Regulatory Affairs and Quality Assurance from Temple University or a peer institution. An advanced degree in the sciences is also accepted.
Applicants who did not earn their master's degree from Temple University's School of Pharmacy must formally apply to the certificate program. They must provide proof of their advanced degree, including a transcript and documentation of the titles and descriptions of previous RA/QA courses taken. A summary of their industry experience in the form of a CV or resume is also required.
Bachelor's Degree in Discipline/Related Discipline: Applicants completing the program to earn a graduate certificate must hold a BS degree in Biochemistry, Biology, Chemistry, Physics or a health-related discipline.
Certificate Requirements
Number of Credits Required to Complete the Certificate: 12-15, depending on the institution from which and/or the subject in which the master's degree was earned1
Required Courses:
| Code | Title | Credit Hours |
|---|---|---|
| Select four or five from the following approved courses: | 12-15 | |
| Development of Sterile Products | ||
| Pharmaceutical Biotechnology | ||
| Introduction to Toxicology | ||
| Advanced Pharmacogenomics | ||
| Special Topics in Regulatory Affairs and Quality Assurance | ||
| Fundamentals of Pharmacology and Pharmacokinetics | ||
| Pharmacoeconomics | ||
| Statistical Quality Control | ||
| Global Biopharmaceutical Industry | ||
| Pharmaceutical Laboratory Quality Systems and Operations | ||
| Biotechnology: Bioprocess Basics | ||
| Pharmaceutical Marketing | ||
| Generic Drug Regulation (ANDAs) | ||
| Process Validation | ||
| Good Laboratory Practices | ||
| Good Manufacturing Practices | ||
| High Purity Water Systems | ||
| Advanced Good Manufacturing Practices - Defining "c" | ||
| Pre-Approval Inspections | ||
| Production of Sterile Parenterals | ||
| Sterilization Processes | ||
| Quality Audit | ||
| Investigational New Drug/New Drug Application Submissions | ||
| Regulation of Medical Devices: Compliance | ||
| Statistics for Clinical Trials | ||
| Computerized System Validation | ||
| Drug Dosage Forms | ||
| Regulation of Medical Devices: Submissions | ||
| Global Regulation of Medical Devices | ||
| Environmental Law and Regulation (EPA) | ||
| Good Pharmacovigilance Operations | ||
| Advanced Audit Workshop of Quality Systems | ||
| Microbiological Concepts in Pharmaceutical Manufacturing | ||
| Active Pharmaceutical Ingredients (APIs) | ||
| Biologics/Biosimilars: A Regulatory Overview | ||
| Cleaning Validation | ||
| Global Labeling Regulation: Principles and Practices | ||
| Requirements for Product Labeling and Advertising | ||
| Regulatory Aspects of Biomedical/Technical Communication | ||
| Advanced Topics in Labeling Development | ||
| Good Clinical Practices | ||
| Clinical Trial Management | ||
| Clinical Drug Safety and Pharmacovigilance | ||
| Global Clinical Drug Development | ||
| Pharmaceutical Packaging: Technology and Regulation | ||
| Good Distribution Practices | ||
| Regulatory Intelligence | ||
| Post Approval Changes (PAC) | ||
| Global Pharmaceutical Excipient Regulation | ||
| Project Management for Clinical Trials | ||
| Post-Marketing Safety Surveillance | ||
| Vaccines: Regulatory Affairs and Quality Assurance Issues | ||
| Pharmacoepidemiology | ||
| Pharmaceutical Quality Management Systems | ||
| Regulatory Sciences: Managing the Guidelines to Quality | ||
| Global CMC Issues and Regulatory Dossier | ||
| Global CMC Regulatory Compliance for Biopharmaceuticals and Other Biologics | ||
| Benefit Risk Management and Safety Signaling of Healthcare Products | ||
| Regulatory and Legal Basis of Pharmacovigilance | ||
| Global Regulatory Affairs | ||
| Regulation of Dietary Supplements and Functional Foods | ||
| Food Law | ||
| Food Labeling and Regulatory Affairs | ||
| Clinical Aspects of Pharmaceutical Medicine | ||
| Industry Interactions with FDA/Health Authorities | ||
QARA 5602 | ||
| Advanced Topics in Food and Drug Law | ||
| Regulation of Advertising and Promotions | ||
| Bioethics for Pharmaceutical Professionals | ||
| Project Management for Pharmaceutical Professionals | ||
| Clinical Data Management (CDM) | ||
| Unit Operations | ||
| Process Analytical Technology (PAT) | ||
| Statistical Design of Experiments (DOE) | ||
| Process Monitoring | ||
| Analytical Chemistry in Pharmaceutical Laboratories | ||
| Pharmaceutical Analysis | ||
| Preformulation - Small Molecules | ||
| Solid Dosage Forms: Small Molecules | ||
| Physical Pharmacy I | ||
| Applied Biopharmaceutics | ||
| Total Credit Hours | 12-15 | |
- 1
Students who earned their MS in Regulatory Affairs and Quality Assurance from Temple University's School of Pharmacy are permitted to select any four 3-credit courses not previously completed as part of their MS curriculum. Those who earned a master's degree in Regulatory Affairs and Quality Assurance from a peer institution, as well as those holding an advanced degree in the sciences, are required to take five 3-credit courses.
GPA Required to be Awarded the Certificate: 3.0 minimum
Contacts
Certificate Program Web Address:
Department Information:
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728
267-468-8560
Mailing Address for Application Materials:
Temple University
Regulatory Affairs and Quality Assurance Graduate Program
425 Commerce Drive, Suite 175
Fort Washington, PA 19034-2728