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 | |
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 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 | |
Clinical Aspects of Pharmaceutical Medicine | 5599 | |
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 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. |
| |
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 |