Online Courses, Certificates, and Degree Programs
Yes. You can complete all of our Regulatory Affairs and Quality Assurance (RAQA) graduate programs entirely online.
This includes all of our courses and all of our certificates:
Drug Development - Basic Pharmaceutical Development - Biopharmaceutical Manufacturing and RA - Biologics and Biosimilars: Manufacturing - Biologics and Biosimilars: Regulatory Affairs - Clinical Trial Management - Food RA and QA - Generic Drugs - Global Pharmacovigilance: Benefit/Risk Assessment - Labeling, Advertising and Promotions - Medical Devices - Pharmaceutical Manufacturing: Process Developent and Analysis - Sterile Process Manufacturing - Validation Sciences - Post Master's Certificates in Advanced QA and RA.
Online courses are offered in real time. You participate in class each week at a specific time, watching your instructor's live lecture. The learning material is fresh and new and enables you to interact with other professionals across the country and world.
Online technology (Zoom) allows you to watch and participate in classes using a computer with a high-speed internet connection. You can:
- see and hear your teacher in a live transmission,
- answer questions and participate in discussions with a microphone headset or instant chat,
- watch PowerPoint presentations and short videos,
- participate in class polls, seeing the results immediately,
- give live presentations using a microphone and webcam.
We offer all of the required courses for the MS in RA and QA online, including:
Drug Development (5459)
Food and Drug Law (5592)
Good Manufacturing Practices (5477)
Good Clinical Practices (5536)
Good Laboratory Practices (5476)
Advanced GMPs - Defining "c" (5479)
IND/NDA Submissions (5495)
Quality Audit (5494)
Plus all of our electives are online:
Fundamentals of Pharmacology & Pharmacokinetics (5401)
Pharmacoeconomics (5408)
Statistical Quality Control (5451)
The Global Biopharmaceutical Industry (5458)
Validation of Facilities, Utilities, and Equipment (FUE) (5468)
Pharmaceutical Laboratory Quality Systems and Operations (5469)
Biotechnology: Bioprocess Basics (5471)
Pharmaceutical Marketing (5472)
Generic Drug Regulation: ANDAs (5473)
Process Validation (5474)
High Purity Water Systems (5478)
Pre-Approval Inspections (5491)
Production of Sterile Products (5492)
Sterilization Processes: Manufacturing (5493)
Regulation of Medical Devices: Compliance (5496)
Statistics for Clinical Trials (5497)
Computerized Systems Validation (5498)
Drug Dosage Forms (5499)
Development of Sterile Products (5501)
Regulation of Medical Devices: Submissions (5502)
Design Controls for Medical Devices and Combination Products (5503)
Global Regulation of Medical Devices (5505)
Environmental Law and Regulatio (EPA) (5506)
Regulation of Non-Prescription Drugs (OTCs) (5507)
Good Pharmacovigilance Operations (5508)
Advanced Audit Workshop of Quality Systems (5511)
Microbiological Concepts in Pharmaceutical Manufacturing (5512)
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 and Regulation (5541)
Good Distribution Practices (GCPs) (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 for 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 and Functional Food (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)
Regulatory Strategy: Discovery to Approval (5606)
Regulation of Advertising and Promotions (5611)
Bioethics for Pharmaceutical Professionals (5612)
Project Management for Pharmaceutical Professionals (5621)
Clinical Data Management (5618)
Regulatory Bioanalysis (5621)
Unit Operations (5622)
Process Analytical Technology (PAT) (5625)
Statistical Design of Experiments (5627)
Process Monitoring (5629)
Current Global Regulatory Issues (5650)
ICH Guidelines (5650)
Current Medical Device Issues (5650)
Analytical Chemistry in Pharmaceutical Laboratories (5655)
Preformulation: Small Moleculres (formerly Pharmaceutical Manufacturing I: Preformulation/Formulation) (8003)
Solid Dosage Forms: Small Molecules (formerly Pharmaceutical Manufacturing II: Solid Dosage Form)s (8004)
Pharmaceutical Biotechnology (8005)
Physical Pharmacy I (8006)
Applied Biopharmaceutics (8007)
Our courses combine the immediate exchange of knowledge found in traditional classroom learning with the convenience and flexibility of online learning. As long as you have a laptop or computer with a high-speed connection, you can attend class at home, in your office, or on the road.
You must purchase a microphone headset and webcam to participate in our online courses. These items enable your instructors and other students to see and hear you during class meetings, enhancing everyone's class experience.
Our lectures are live, since class dialogue and interaction are so critical to understanding quality and regulatory principles. Our online classes offer the same outstanding curriculum as our classroom courses at Fort Washington and are taught by the same instructors. To find out more or to ask for a brochure, email qara@temple.edu.
Temple’s RA and QA graduate program is also happy to videoconference courses directly to pharmaceutical companies. Contact qara@temple.edu for more information.