Elective Courses (RAQA)
Elective Courses
| Special Topics - RAQA | 5000 | |
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Fundamentals of Pharmacology and Pharmacokinetics |
5401 |
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Pharmacoeconomics |
5408 |
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Statistical Quality Control |
5451 |
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Acceptance Sampling |
5452 |
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The Global Biopharmaceutical Industry |
5458 |
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| Validation of FUE (Facilities, Utilities and Equipment) | 5468 | |
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Pharmaceutical Laboratory Quality Systems & Operations |
5469 |
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Biotechnology: Bioprocess Basics |
5471 |
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Pharmaceutical Marketing |
5472 |
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Generic Drug Regulation (ANDAs) |
5473 |
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Process Validation |
5474 |
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Good Laboratory Practices |
5476 |
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Good Manufacturing Practices |
5477 |
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High Purity Water Systems |
5478 |
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Advanced Good Manufacturing Practices - Defining “c” |
5479 |
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Pre-Approval Inspections |
5491 |
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Productions of Sterile Parenterals |
5492 |
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Sterilization Processes: Manufacturing |
5493 |
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Quality Audit |
5494 |
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IND/NDA Submissions |
5495 |
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Regulation of Medical Devices: Compliance |
5496 |
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Statistics for Clinical Trials |
5497 |
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Computerized Systems Validation |
5498 |
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Drug Dosage Forms |
5499 |
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Regulations of Medical Devices: Submissions |
5502 |
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| Design Controls for Medical Devices and Combination Products | 5503 | |
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Global Regulation of Medical Devices |
5505 |
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Environmental Law and Regulation (EPA) |
5506 |
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| Regulation of Non-Preswcription Healthcare Products | 5507 | |
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Good Pharmacovigilance Operations |
5508 |
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Advanced Audit Workshop of Quality Systems |
5511 |
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Microbiological Concepts in Pharmaceutical Manufacturing |
5512 |
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| Active Pharmaceutical Ingredients (APIs) | 5513 | |
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Regulatory eSubmissions |
5514 |
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Biologics/Biosimilars: A Regulatory Overview |
5515 |
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Cleaning Validation |
5516 |
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Regulatory Issues in Pharmacogenomics |
5518 |
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| Global Labeling Regulation: Principles and Practices | 5532 | |
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Requirements for Product Labeling and Advertising |
5533 |
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Regulatory Aspects of Biomedical/Technical Communications |
5534 |
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Advanced Topics in Labeling Development |
5535 |
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Good Clinical Practices |
5536 |
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Clinical Trial Management |
5537 |
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Clinical Drug Safety and Pharmacovigilance |
5538 |
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Global Clinical Drug Development |
5539 |
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Pharmaceutical Packaging: Technology & Regulation |
5541 |
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Regulation of Training: Compliance |
5542 |
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Good Distribution Practices |
5543 |
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| Regulatory Intelligence | 5544 | |
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Post Approval Changes (PAC) |
5545 |
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Global Pharmaceutical Excipient Regulation |
5546 |
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| Project Management for Clinical Trials | 5547 | |
| Risk Management for Pharmaceutical and Medical Devices | 5548 | |
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Post-Marketing Safety Surveillance |
5571 |
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Vaccines: RA and QA Issues |
5572 |
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Pharmacoepidemiology |
5573 |
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| Pharmaceutical Quality Management Systems | 5574 | |
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Regulatory Sciences: Managing the Guidelines for Quality |
5575 |
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Global CMC Issues and Regulatory Dossiers |
5576 |
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| Global CMCs for Biopharmaceuticals | 5577 | |
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Risk Management and Safety Signaling of Healthcare Products |
5578 |
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Regulatory & Legal Basis of Pharmacovigilance |
5579 |
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Global Regulatory Affairs |
5591 |
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Regulation of Dietary Supplements and Funcation Food |
5594 |
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| Food Law | 5595 | |
| Food Labeling and Regulatory Affairs | 5596 | |
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Food GMPs |
5597 |
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Clinical Aspects of Pharmaceutical Medicine |
5599 |
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Industry Interactions with FDA and Health Authorities |
5601 |
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Advanced Topics in Food and Drug Law |
5605 |
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Regulation of Advertising and Promotions |
5611 |
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Bioethics for Pharmaceutical Professionals |
5612 |
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Project Management for Pharmaceutical Professionals |
5615 |
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Clinical Data Management |
5618 |
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| Regulatory Bioanalysis | 5621 | |
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Unit Operations |
5622 |
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Process Analytical Technology (PAT) |
5625 |
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Statistical Design of Experiments (DOE) |
5627 |
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Process Monitoring |
5629 |
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Special Topics in RAQA |
5650 |
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| Analytical Chemistry in Pharmaceutical Laboratories | 5655 | |
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RAQA students may also take electives from the MS in Pharmaceutical Regulatory Sciences; however, a strong science background is required, since these courses are taught from a pharmaceutical science viewpoint and not a regulatory/QA perspective. This consists of a minimum of two years of general chemistry, including one organic and one analytical chemistry course. RAQA students must include their resume for permission to register in these courses. |
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Production of Sterile Products |
5492 |
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Development of Sterile Products |
5501 |
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Pharmaceutical Analysis |
8002 |
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Pharmaceutical Manufacturing I: Preformulation/Formulation |
8003 |
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Pharmaceutical Manufacturing II: Solid Dosage Forms |
8004 |
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Pharmaceutical Biotechnology |
8005 |
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Physical Pharmacy I |
8006 |
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Applied Biopharmaceutics |
8007 |
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Introduction to Toxiocology |
8111 |
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Physical Pharmacy II |
8582 |