Earn Your M.S. in Regulatory Affairs and Quality Assurance or Certificate Online

Nearly every course* in the RAQA graduate program is offered online in real time.  That means you can earn nearly every certificate and the entire M.S. in Regulatory Affairs and Quality Assurance from the comfort of your home without ever having to commute to our campus.

Online courses make it even easier for you to further your career with advanced education.  You can earn graduate credits from home, the office or on the road.

We use Zoom for our online courses.  When you register for one of our RAQA courses, we automatically cover the licensing fees for you to use this program.  All you need is a computer, a high-speed Internet connection, a microphone headset and a webcam.  These tools enable you to see and hear your instructor and classmates, follow and participate in discussions, view class documents, share screens, ask questions and even watch and give presentations.

Temple also offers videoconferencing services to pharmaceutical companies and institutions. Contact qara@temple.edu to find out more.

All Required Courses for the M.S. in RAQA are Available Online

• Drug Development (5459)
• Food and Drug Law (5592)
• GxP course, including Good Manufacturing Practices (5477), Good Clinical Practices (5536), Good Laboratory Practices (5476), and Advanced GMPs (5479)
• IND/NDA Submissions (5495) or Quality Audit (5494)

Elective Courses for the M.S. in RAQA that are available Online

Fundamentals of Pharmacology & Pharmacokinetics (5401)
Pharmacoeconomics (5408)
Statistical Quality Control (5451)
The Global Biopharmaceutical Industry (5458)
Validation of Facilities, Utilities and Quipment (FUE) (5468)
Biotechnology:  Bioprocess Basics (5471)
Pharmaceutical Marketing (5472)
Generic Drug Regulation (ANDAs) (5473)
Process Validation (5474)
High Purity Water Systems (5478)
Pre-Approval Inspections (5491)
Regulation of Medical Devices: Compliance (5496)
Pre-Approval Inspections (5491)
Production of Sterile Products (5492)
Sterilization Processes (5493)
Computer Validation (5498)
Regulation of Medical Devices: Submissions (5502)
Statistics for Clinical Trials (5497)
Computerized Systems Validation (5498)
Drug Dosage Forms (5499)
Regulation of Medical Devices:  Submissions (5502)
Medical Device Design Controls (5503)
Global Medical Device Regulation (5505)
Good Pharmacovigilance Operations (5508)
Active Pharmaceutical Ingredients (APIs) (5513)
Regulatory eSubmissions (5514)
Biologics/Biosimilars: A Regulatory Overview (5515)
Cleaning Validation (5516)
Global Labeling Regulation:  Principles and Practices (5532)
Requirements for Product Labeling and Advertising (5533)
Regulatory Aspects of Biomedical/Technical Communications (5534)
Advanced Topics in Labeling Development (5535)
Clinical Trial Management (5537)
Clinical Drug Safety and Pharmacovigilance (5538)
Global Clinical Drug Development (5539)
Pharmaceutical Packaging:  Technology & Regulation (5541)
Good Distribution Practices (5543)
Regulatory Intelligence (5544)
Post Approval Changes (5545)
Global Pharmaceutical Excipient Regulation (5546)
Project Management for Clinical Trials (5547)
Risk Management of Pharmaceutical and Medical Devices (5548)
Post Marketing Safety Surveillance (5571)
Vaccines:  RA and QA Issues (5572)
Pharmacoepidemiology (5573)
Pharmaceutical Quality Management Systems (5574)
Regulatory Sciences:  Managing the Guidelines for Quality (5575)
Global CMCs and Regulatory Dossiers (5576)
Global CMCs- Biologics (5577)
Risk Management and Safety Signaling of Healthcare Products (5578)
Regulatory and Legal Basis of Pharmacovigilance (5579)
Global Regulatory Affairs (5591)
Regulation of Dietary Supplements, Botanicals and Nutraceuticals (5594)
Food Law (5595)
Food Labeling and Regulatory Affairs (5596)
Food GMPs (5597)
Clinical Aspects of Pharmaceutical Medicine  (5599)
Industry Interactions with FDA/Health Authorities (5601)
Advanced Topics in Food and Drug Law (5605)
Regulation of Advertising and Promotions (5611)
Bioethics for Pharmaceutical Professionals (5612)
Project Management for Pharmaceutical Professionals (5615)
Clinical Data Management (5618)
Unit Operations (5622) 
Statistical Design of Experiments (DOE) (5627)
Process Monitoring (5629)
Special Topics:  FDA Medical Device Regulation (5650)
Special Topics:  Latest Trends &Developments in Clinical Trials (5650)
Special Topics in RAQA:  Regulation of Pediatric and Orphan Drugs (5650
Analytical Chemistry in Pharmaceutical Laboratories (5655)
Pharmaceutical Manufacturing II:  Solid Dosage Forms (8004)
Pharmaceutical Biotechnology (8005)

*Courses are not offered every semester.  Required courses for the MS are usually offered each semester.  Elective courses are rotated over a two- or three-year period.

Certificates Offered Online

Pre-Master's Certificates
Drug Development
Clinical Trial Management
Medical Devices
Global Pharmacovigilance: Benefit-Risk Assessment
Labeling, Advertising and Promotions
Biosimlars and Generic Drugs
Food RA and QA
Biopharmaceutical Manufacturing and RA (Biotechnology) 
Sterile Process Manufacturing
Basic Pharmaceutical Development

Post-Master's Certificates
Post Master's Certificates in Advanced QA and RA
Post Master's Certificate in Biopharmacetical Manufacturing and RA (Biotechnology)
Post Master's Certificate in Biosimilars and Generic Drugs
Post-Master's Certificate in Clinical Trial Management
Post Master's Certificate in Food RA and QA
Post-Master's Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment
Post-Master's Certificate in GMPs for the 21st Century
Post-Master's Certificate in Labeling, Advertising, and Promotions
Post Master's Certificate in Medical Devices 
Post Master's Certificate in Sterile Process Manufacturing