Elective Courses (RAQA)

Elective Courses

Special Topics - RAQA5000 

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 Products5503 

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 Practices5532 

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 Intelligence5544 

Post Approval Changes (PAC)

5545

 

Global Pharmaceutical Excipient Regulation

5546

 
Project Management for Clinical Trials5547 
Risk Management for Pharmaceutical and Medical Devices5548 

Post-Marketing Safety Surveillance

5571

 

Vaccines:  RA and QA Issues

5572

 

Pharmacoepidemiology

5573

 
Pharmaceutical Quality Management Systems5574 

Regulatory Sciences:  Managing the Guidelines for Quality

5575

 

Global CMC Issues and Regulatory Dossiers

5576

 
Global CMCs for Biopharmaceuticals5577 

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 Law5595 
Food Labeling and Regulatory Affairs5596 

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 Bioanalysis5621 

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 Laboratories5655 

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