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See the future of QA/RA... Now. 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 Global CMCs and Regulatory Dossiers Pharmaceutics 5576 Risk Management/Safety Signaling Healthcare Products Pharmaceutics 5578 Regulatory and Legal Basis of Pharmacovigilance Pharmaceutics 5579 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


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