Quality Assurance/Regulatory Affairs

General Statement

The Master of Science degree in Quality Assurance and Regulatory Affairs is a part-time program designed to prepare individuals for middle management positions in the pharmaceutical industry. This program is also suitable for those planning a career in regulatory agencies, such as the Food and Drug Administration. The lecture portion of the program is conducted primarily at Temple University's Fort Washington campus on weekday evenings during fall, spring, and summer semesters. Additional lecture courses are taught on a weekend schedule to accommodate diverse student schedules. In some instances, courses will be provided as a concentrated series on consecutive days in a retreat or symposium.

Application Deadline

There is no deadline for applications. This program has open enrollment.

Admission Requirements

Prerequisites for the program include a scientifically or clinically oriented bachelor’s degree in the life sciences, chemistry, or health care with a grade point average of no less than 3.0. Experience in the pharmaceutical industry is desirable but not essential for acceptance. Candidates wishing to apply to the program must take the general Graduate Record Examination (GRE) and score at least in the 50th percentile, and submit a formal application to the program.

Degree Requirements

This master’s degree program requires a minimum of 30 credits in lecture courses and four credits in Special Problems which offers an opportunity for field experience with issues facing the pharmaceutical industry. As an option, the four research project credits of Special Problems in QA/RA (987) can be replaced with two (2) additional three-credit courses in pharmaceutics. If this option is chosen, the total number of credits necessary is thirty-six (36). Time limit for completing the degree program is five (5) years.

Required Courses

459. Drug Development
487. Good Manufacturing Practices
494. Quality Audit
592. Food and Drug Law I
987. Special Problems in QA/RA or two
(2) additional three-credit courses
in Pharmaceutics

Note: The following courses from other Temple colleges and departments may be taken as electives (up to 6 credits) with special permission from the Director of Graduate Studies:

Management Information Systems (CIS 410)

Managerial Cost Accounting (Accounting 521)

Management and Organization Behavior (HRA 401)

Managing Human Resources (HRA 520)

Organizational Staffing and Career Management (HRA 521)

Training and Development (HRA 522)

Project Management (508)

Power, Influence and Negotiation   (Management 513)

Total Quality Management   (MSOM 507)

Course Descriptions -- Pharmaceutical Sciences and Quality Assurance/Regulatory Affairs

Pharmaceutical Sciences

449. Radioisotope Methodology. (3 s.h.)

Introductory discussion of the characteristics and properties of ionizing radiation, methods of detection (gas ionization, scintillation, both liquid and solid spectroscopy), radiation standards for safety and protection, and basic evaluation of biological hazards and effects.

454. Biopharmaceutical Importance of Drug Formulation. (3 s.h.)

Deals with the process of drug absorption from extravascular sites in the body. It will cover biopharmaceutical factors which influence bioavailability and the subsequent use of this knowledge to optimize clinical success in the use of drug products.

460. Metabolism of Drugs and Chemicals. (2 s.h.)

Deals with the metabolism and detoxification of drugs, toxic substances, and other organic compounds, with particular attention to the influence these processes exert on drug therapy.

464. Abuses of Drugs and Chemicals. (2 s.h.)

Provides information about drug substances and related chemicals subject to abuse, the extent of drug abuse, factors fostering drug abuse, treatment methods and rehabilitation programs, community education and involvement, and planning to counter drug abuse.

471. Practical Chromatography. (3 s.h.)

Techniques of HPLC and Capillary Gas Chromatography as they apply to the operation of modern computer controlled instrumentation. Emphasis is placed on drug-related research (Medicinal Chemistry, Pharmacology and Pharmaceutics). A "hands-on" approach including laboratory exercises is employed.

475. Pharmaceutical Biotechnology: Methods and Aspects of Pharmaceutical Formulations of Biotech Products. (3 s.h.)

This course will introduce students to pharmaceutical biotechnology, biophysical, and chemical aspects of biotech products and their pharmaceutical formulations and clinical applications. Amino acids, proteins, peptides, and nucleotides are of particular interest. The principles of pharmaceutical formulation of biotech products and physicochemical evaluation of formulations will be extensively discussed. Also, pharmacokinetics of biologics and current analytical methods used in pharmaceutical biotechnology will be focused.

477. Protein Pharmaceuticals. (3 s.h.)

478. Extended Release Dosage Forms. (3 s.h.)

The fundamentals involved in various extended release dosage forms and their modification for use in particular dosage formulations. Biopharmaceutical and pharmacokinetic aspects of extended-release dosage forms are discussed as well. Overview of polymeric excipients used in the formulation of extended-release dosage forms. Current commercial products under development will be discussed.

485. Physical Pharmacy: Energetics of Pharmaceutical and Biochemical Processes. (3 s.h.)

Application of the concepts of physical chemistry and thermodynamics to pharmaceutical systems, including solutions, heterogeneous systems, biochemical transformations, and membranes. Introductory level.

489-490. Product Development I and II. (3 s.h. each)

Drug stabilization by demonstration and laboratory exercises using various methods of evaluation. Practical application of kinetics, statistics, and chemical and physical tests.

492. Sterile Products: Parenterals. (3 s.h.)

A study of the theory and principles involved in the preparation of sterile, pyrogen-free products. Understanding the manufacturing procedures related to sterile products. Clinical applications as well as aseptic technique.

499. Drug Dosage Forms. (3 s.h.)

Overview of drug dosage form design and manufacturing technology. Principles of pharmaceutical processing, pharmaceutical dosage form design, including preformulation and biopharmaceutics. Various dosage forms will be discussed, e.g., tablets, capsules, modified dosage forms, semi-solid products, transdermal delivery systems, etc.

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