Online Learning in Quality Assurance and Regulatory Affairs

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

Over 50 courses* in the QA/RA graduate program are offered online in real time.  That means you can earn nearly every certificate and the entire M.S. in QA/RA 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 a platform called Adobe Connect.  When you register for one of our QA/RA 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.

Eleven courses in the non-thesis M.S. program in Pharmaceutics are also offered online.

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 QA/RA are Available Online

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

Elective Courses for the M.S. in QA/RA that are available Online

Fundamentals of Pharmacology & Pharmacokinetics (Pharmaceutics 5401)
Pharmacoeconomics (Pharmaceutics 5408)
Pharmaceutical Marketing (Pharmaceutics 5472)
Generic Drug Regulation (ANDAs) (Pharmaceutics 5473)
Process Validation (Pharmaceutics 5474)
High Purity Water Systems (Pharmaceutics 5478)
Regulation of Medical Devices: Compliance (Pharmaceutics 5496)
Computer Validation (Pharmaceutics 5498)
Regulation of Medical Devices:  Submissions (Pharmaceutics 5502)
Global Medical Device Regulation (Pharmaceutics 5505)
Good Pharmacovigilance Operations (Pharmaceutics 5508)
Active Pharmaceutical Ingredients (APIs) (Pharmaceutics 5513)
Biologics/Biosimilars: A Regulatory Overview (Pharmaceutics 5515)
Cleaning Validation (Pharmaceutics 5516)
Requirements for Product Labeling and Advertising (Pharmaceutics 5533)
Regulatory Aspects of Biomedical/Technical Communications (Pharmaceutics 5534)
Advanced Topics in Labeling Development (Pharmaceutics 5535)
Clinical Trial Management (Pharmaceutics 5537)
Clinical Drug Safety and Pharmacovigilance (Pharmaceutics 5538)
Global Clinical Drug Development (Pharmaceutics 5539)
Post Approval Changes (Pharmaceutics 5545)
Global Pharmaceutical Excipient Regulation (Pharmaceutics 5546)
Project Management for Clinical Trials (Pharmaceutics 5547)
Post Marketing Safety Surveillance (Pharmaceutics 5571)
Pharmacoepidemiology (Pharmaceutics 5573)
Regulatory Sciences:  Managing the Guidelines for Quality (Pharmaceutics 5575)
Risk Management and Safety Signaling of Healthcare Products (Pharmaceutics 5578)
Regulatory and Legal Basis of Pharmacovigilance (Pharmaceutics 5579)
Global CMCs and Regulatory Dossiers (Pharmaceutcs 5586)
Global Regulatory Affairs (Pharmaceutics 5591)
Regulation of Dietary Supplements, Botanicals and Nutraceuticals (Pharmaceutics 5594)
Food Law (Pharmaceutics 5595)
Food Labeling and Regulatory Affairs (Pharmaceutics 5596)
Clinical Aspects of Pharmaceutical Medicine I (Pharmaceutics 5599)
Industry Interactions with FDA/Health Authorities (Pharmaceutics 5601)
Clinical Aspects of Pharmaceutical Medicine II (Pharmaceutics 5602)
Advanced Topics in Food and Drug Law (Pharmaceutics 5605)
Bioethics for Pharmaceutical Professionals (Pharmaceutics 5612)
Special Topics:  FDA Medical Device Regulation (Pharmaceutics 5650)
Analytical Chemistry in Pharmaceutical Laboratories (Pharmaceutics 5655)
Pharmaceutical Manufacturing II:  Solid Dosage Forms (Pharmaceutics 8004)
Pharmaceutical Biotechnology (Pharmaceutics 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
Biopharmaceuticals and Generic Drugs
Basic Pharmaceutical Development

Post-Master's Certificates
Post Master's Certificates in Advanced QA/RA
Post-Master's Certificate in Clinical Trial Management
Post-Master's Certificate in Medical Devices
Post-Master's Certificate in Global Pharmacovigilance:  Benefit-Risk Assessment
Post-Master's Certificate in Biopharmaceuticals and Generic Drugs