Elective Courses

Fundamentals of Pharmacology and Pharmacokinetics	5401
Pharmacoeconomics	5408
Statistical Quality Control	5451
Acceptance Sampling	5452
Global Biopharmaceutical Industry ( including Waxman Hatch)	5458
Pharmaceutical Laboratory Quality Systems & Operations	5469
Biotechnology:  Bioprocess Basics	5471
Pharmaceutical Marketing	5472
Generic Drug Regulation (ANDAs)	5473
Process Validation	5474
Good Laboratory Practices	5476
Good Manufacturing Practices	5477
High Purity Water Systems	5478
Advanced Good Manufacturing Practices - Defining “c”	5479
Pre-Approval Inspections	5491
Productions of Sterile Parenteral Products	5492
Sterilization Processes:  Manufacturing	5493
Quality Audit	5494
IND/NDA Submissions	5495
Regulation of Medical Devices: Compliance	5496
Statistics for Clinical Trials	5497
Computer Validation	5498
Drug Dosage Forms	5499
Regulations of Medical Devices: Submissions	5502
Global Regulation of Medical Devices	5505
Environmental Law and Regulation (EPA)	5506
Good Pharmacovigilance Operations	5508
Advanced Audit Workshop of Quality Systems	5511
Microbiological Concepts in Pharmaceutical Manufacturing	5512
Biologics/Biosimilars: A Regulatory Overview	5515
Cleaning Validation	5516
Regulatory Issues in Pharmacogenomics	5518
Requirements for Product Labeling and Advertising	5533
Regulatory Aspects of Biomedical/Technical Communications	5534
Advanced Topics in Labeling Development	5535
Good Clinical Practices	5536
Clinical Trial Management	5537
Clinical Drug Safety & Pharmacovigilance	5538
Global Clinical Drug Development	5539
Pharmaceutical Packaging:  Technology & Regulation	5541
Regulation of Training:  Compliance	5542
Good Distribution Practices	5543
Regulatory Intelligence	5544
PAC (Post Approval Changes)	5545
Global Pharmaceutical Excipient Regulation	5546
Project Management for clinical Trials	5547
Post-Marketing Safety Surveillance	5571
Vaccines:  QA/RA Issues	5572
Pharmacoepidemiology	5573
Pharmaceutical Quality Management Systems	5574
Regulatory Sciences:  Managing the Guidelines for Quality	5575
Global CMC Issues and Regulatory Dossiers	5576
Risk Management/Safety Signaling of Healthcare Products	5578
Regulatory & Legal Basis of Pharmacovigilance	5579
Advanced Topics in Regulatory Aspects of Biomedical/Technical Communication	5589
Global Regulatory Affairs	5591
Regulation of Dietary Supplements, Botanicals and Nutraceuticals	5594
Food Law	5595
Clinical Aspects of Pharmaceutical Medicine I	5599
Industry Interactions with FDA/Health Authorities	5601
Clinical Aspects of Pharmaceutical Medicine II	5602
Advanced Topics in Food and Drug Law	5605
Advanced Topics:  Regulation of Advertising and Promotions	5611
Bioethics for Pharmaceutical Professionals	5612
Project Management for Pharmaceutical Professionals	5615
Clinical Data Management	5618
Unit Operations	5622
Process Analytical Technology (PAT)	5625
Statistical Design of Experiments (DOE)	5627
Process Monitoring	5629
Special Topics in QA/RA	5650
Analytical Chemistry in Pharmaceutical Laboratories	5655
QA/RA students may also take electives from the non-thesis MS in Pharmaceutics; however, a strong science background is required, since these courses are taught from a pharmaceutical science viewpoint and not a regulatory/QA perspective.
Production of Sterile Parenterals	5492
Development of Sterile Parenterals	5501
Pharmaceutical Analysis	8002
Pharmaceutical Manufacturing I: Preformulation/Formulation	8003
Pharmaceutical Manufacturing II:  Solid Dosage Forms	8004
Pharmaceutical Biotechnology	8005
Physical Pharmacy I	8006
Applied Biopharmaceutics	8007
Principles of Pharmacokinetics	8008
Introduction to Toxiocology	8111
Pharmacodynamics	8402
Pharmacogenomics	8403
Extended Release Dosage Forms	8478
Physical Pharmacy II	8582