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 Parenterals

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

Active Pharmaceutical Ingredients (APIs) 5513

Biologics/Biosimilars: A Regulatory Overview

5515

Cleaning Validation

5516

Regulatory Issues in Pharmacogenomics

5518

Global Labeling Regulation 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 & 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

Global Regulatory Affairs

5591

Regulation of Dietary Supplements, Botanicals and Nutraceuticals

5594

Food Law 5595
Food Labeling and Regulatory Affairs 5596

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