Elective Courses
| Special Topics - RAQA | 5000 | |
Fundamentals of Pharmacology and Pharmacokinetics | 5401 | |
Pharmacoeconomics | 5408 | |
Statistical Quality Control | 5451 | |
Acceptance Sampling | 5452 | |
The Global Biopharmaceutical Industry | 5458 | |
| Validation of FUE (Facilities, Utilities and Equipment) | 5468 | |
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 Parenterals | 5492 | |
Sterilization Processes: Manufacturing | 5493 | |
Quality Audit | 5494 | |
IND/NDA Submissions | 5495 | |
Regulation of Medical Devices: Compliance | 5496 | |
Statistics for Clinical Trials | 5497 | |
Computerized Systems Validation | 5498 | |
Drug Dosage Forms | 5499 | |
Regulations of Medical Devices: Submissions | 5502 | |
| Design Controls for Medical Devices and Combination Products | 5503 | |
Global Regulation of Medical Devices | 5505 | |
Environmental Law and Regulation (EPA) | 5506 | |
| Regulation of Non-Preswcription Healthcare Products | 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 | |
Regulatory Issues in Pharmacogenomics | 5518 | |
| 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 | |
Good Clinical Practices | 5536 | |
Clinical Trial Management | 5537 | |
Clinical Drug Safety and Pharmacovigilance | 5538 | |
Global Clinical Drug Development | 5539 | |
Pharmaceutical Packaging: Technology & Regulation | 5541 | |
Regulation of Training: Compliance | 5542 | |
Good Distribution Practices | 5543 | |
| Regulatory Intelligence | 5544 | |
Post Approval Changes (PAC) | 5545 | |
Global Pharmaceutical Excipient Regulation | 5546 | |
| Project Management for Clinical Trials | 5547 | |
| Risk Management for 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 CMC Issues and Regulatory Dossiers | 5576 | |
| Global CMCs for Biopharmaceuticals | 5577 | |
Risk Management and Safety Signaling of Healthcare Products | 5578 | |
Regulatory & Legal Basis of Pharmacovigilance | 5579 | |
Global Regulatory Affairs | 5591 | |
Regulation of Dietary Supplements and Funcation Food | 5594 | |
| Food Law | 5595 | |
| Food Labeling and Regulatory Affairs | 5596 | |
Food GMPs | 5597 | |
Industry Interactions with FDA and Health Authorities | 5601 | |
Advanced Topics in Food and Drug Law | 5605 | |
Regulation of Advertising and Promotions | 5611 | |
Bioethics for Pharmaceutical Professionals | 5612 | |
Project Management for Pharmaceutical Professionals | 5615 | |
Clinical Data Management | 5618 | |
| Regulatory Bioanalysis | 5621 | |
Unit Operations | 5622 | |
Process Analytical Technology (PAT) | 5625 | |
Statistical Design of Experiments (DOE) | 5627 | |
Process Monitoring | 5629 | |
Special Topics in RAQA | 5650 | |
| Analytical Chemistry in Pharmaceutical Laboratories | 5655 | |
RAQA students with a strong science background (2 years of general chemistry which includes one organic and one analytical chemistry course) may take electives from the MS in Pharmaceutical Regulatory Sciences. These courses are taught from a pharmaceutical science viewpoint and not a regulatory/QA perspective. RAQA students must include their resume for permission to register in these courses. |
| |
Production of Sterile Products | 5492 | |
Development of Sterile Products | 5501 | |
Pharmaceutical Analysis | 8002 | |
Preformulation: Small Molecules (formerly Pharmaceutical Manufacturing I) | 8003 | |
Solid Dosage Forms: Small Molecules (formerly Pharmaceutical Manufacturing II) | 8004 | |
Pharmaceutical Biotechnology | 8005 | |
Physical Pharmacy I | 8006 | |
Applied Biopharmaceutics | 8007 | |
Introduction to Toxiocology | 8111 | |
Physical Pharmacy II | 8582 |