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Study QA/RA Online
Temple University School of Pharmacy
Certificates You Can Complete Online
Certificate Name
Availability
Drug Development
Yes. Can be completed online.
Medical Devices
Clinical Trial Management
Basic Pharmaceutical Development
Biosimilars/Generic Drugs
Global Pharmacovigilance
GMPs for the 21st Century
Post-Master’s Certificates in
Advanced QA and RA
Yes. Can be completed online. All courses available EXCEPT
Pharmaceutical Packaging: Technology & Regulation.
Yes. Can be completed online. All courses available EXCEPT
Clinical Data Management or Statistics for Clinical Trials.
Yes. Can be completed online.
All courses available EXCEPT Project Management.
Yes. Can be completed online. All courses available EXCEPT
Good Distribution Practices and The Global Biopharmaceutical Industry.
Yes. Can be completed online.
No.
Yes. Refer to other side for the list of available courses.
See Expectations of Online Students for more information on student policies, technical requirements, and academic issues.
QA/RA Graduate Program
| Temple University School of Pharmacy
425 Commerce Drive, Suite 175
|
Phone: 267.468.8560
Email: qara@temple.edu
|
|
Fort Washington, PA 19034
Fax: 267.468.8565
www.temple.edu/pharmacy_QARA
Online Course List
The following courses are offered online by the QA/RA graduate program of Temple University's School of Pharmacy*
REQUIRED COURSES FOR THE MS
Note: Drug Development, Food & Drug Law, one GXP course and either Quality Audit or IND/NDA Submissions are required for the MS.
Drug Development
Pharmaceutics 5459
Food and Drug Law I
Pharmaceutics 5592
Quality Audit
Pharmaceutics 5494
IND/NDA Submissions
Pharmaceutics 5495
Good Laboratory Practices
Pharmaceutics 5476
Good Manufacturing Practices
Pharmaceutics 5477
Good Clinical Practices
Pharmaceutics 5536
Advanced GMPs – defining “c”
Pharmaceutics 5479
ELECTIVE COURSES
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
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 (PAC)
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/Safety Signaling Healthcare Products Pharmaceutics 5578
Regulatory and Legal Basis of Pharmacovigilance
Pharmaceutics 5579
Global CMCs and Regulatory Dossiers
Pharmaceutics 5586
Global Regulatory Affairs
Pharmaceutics 5591
Dietary Supplements, Botanicals, 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 and 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
Pharmaceutics 8004
Pharmaceutical Biotechnology
Pharmaceutics 8005
*Not every course listed is offered each semester. Required courses for the MS are usually offered each semester.
Elective courses are rotated over a two or three-year period. Adobe Connect or WebEx are used for online course delivery.
QA/RA Graduate Program
| Temple University School of Pharmacy
425 Commerce Drive, Suite 175
|
Phone: 267.468.8560
Email: qara@temple.edu
|
|
Fort Washington, PA 19034
Fax: 267.468.8565
www.temple.edu/pharmacy_QARA