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Program Overview

The Regulatory Compliance Certificate program is designed to train scientists in the regulatory expertise necessary for a career in regulatory affairs, pharmaceutical or healthcare industries. Courses promote development of the high-tech skills needed to help prepare for the Regulatory Affairs Certification exam sponsored by the Regulatory Affairs Professionals Society.

The certificate program is designed to train scientists interested in developing regulatory expertise necessary for a career in regulatory affairs, pharmaceutical or healthcare industries. Courses are taught in the evenings to accommodate professionals who work full-time.

The courses in the certificate will provide those enrolled in the program with the high-tech skills needed to help prepare for the Regulatory Affairs Certification exam sponsored by the Regulatory Affairs Professionals Society. Steve Giardina, Ph.D., leads the Regulatory Compliance Certificate program. Course topics include standards for laboratory, manufacturing and clinical practice; product development; regulation of medical devices; FDA law, biostatistics; and the intersection of the scientific and regulatory environment in the development of pharmaceuticals.

The Hood Distinction

  • Professors are recognized leaders in their fields
  • Use of state-of-the-art classrooms in the Hodson Science and Technology Center
  • Convenient evening classes
  • Small classes deliver a personalized education
  • 15-credit program
  • Effectively prepares students for the RAC exam

Entrance Requirements

Application
Complete and submit the graduate school application available at www.hood.edu/graduate. The $35 application fee will be waived for online applications.

Requirements
Request one copy of official transcripts from each institution of higher education attended. All documents should be sent directly to the graduate school.

Grade Point Average
A minimum 2.75 undergraduate GPA is required for admission to the graduate school and to the Regulatory Compliance Program.

Courses

The certificate program requires completion of five of the following eight courses:

BMS 513: Biostatistics in Regulatory Applications
(3 credits) This course will provide students with a broad understanding of the application of biostatistics in the regulatory context. Course topics will focus on the basic study design, target population, comparison groups and endpoints for animal studies through clinical trials phase I-IV. Specific emphasis will be placed on addressing issues within the U.S. regulatory environment.

BMS 544: Good Laboratory Practices: A Practical Approach
(3 credits) This course is designed to provide a practical knowledge and understanding of Good Laboratory Practice regulations with examples useful to laboratory workers, study directors and managers. The course will address the current interpretation of the code of federal regulations (21CFR58) and the International Committee on Harmonization.

*BMS 545: Product Development
(3 credits) This course provides an overview of the regulatory process for new biologics, drug and device development. Emphasis is on a strategic development approach and good science standards to ensure safe and effective new therapies for prevention and treatment of disease.

*BMS 546: Good Manufacturing Practice
(3 credits) This course will provide students with an in-depth review of current good manufacturing practice regulations promulgated by the Food and Drug Administration in their regulation of the drug and device industries. Recent FDA regulatory compliance experience regarding the application of the GMP regulations, including areas where industry has failed to correctly apply or interpret current GMPs, will also be examined.

BMS 547: Development of Pharmaceutics and Regulatory Environment
(3 credits) This course examines the interaction of the scientific and regulatory environment required to assure the safety and efficacy of pharmaceutical products for human and veterinary use. The process for development of pharmaceutical products is discussed relative to issues of ethics, environmental protection, validation, audits and business decisions. The regulatory approval processes in developed countries are contrasted to those of developing nations.

*BMS 548: Good Clinical Practice
(3 credits) This course provides a detailed explanation of the guidelines that should be followed when generating clinical data that are intended to be submitted to the Food and Drug Administration in support of a product license. The principles of clinical trial conduct and design can be applied to any investigation involving human subjects.

BMS 549: FDA Regulation of Medical Devices
(3 credits) This course offers an overview of the historical development and current status of laws, regulations and guidelines governing medical devices. The course focuses on key aspects of gaining regulatory approval for all classes of medical devices using various submission processes including the 510 (k) Premarket Notification, the Premarket Approval Application and the Product Development Protocol.

BMS 550: Introduction to FDA Law
(3 credits) This course examines the federal food, drug, biologic, cosmetic and medical device laws and their impact upon research, development, manufacturing and marketing of products. Other topics such as business policy, pharmacoeconomics and quality of life will also be discussed.

*Required courses

Faculty

Faculty in the program include:

Steve Giardina, Ph.D.
Assistant Professor of Biology, Interim Director of Regulatory
Compliance Certificate program
E-mail: giardina@hood.edu
Phone: 301-696-3650

View the brochure.