Bioscience Regulatory Assurance Technologist
The Bioscience Regulatory Assurance Technologist certificate will familiarize students with regulatory principles in bioscience and serve as an introduction to laboratory procedures common in quality management bioscience laboratories. Applicants include individuals interested in changing careers and persons already working in the regulatory assurance industry. The program focuses on not only the regulatory system in the United States, but also the global trends towards international regulatory systems.
Minimum Program Length: 2 Semesters
Estimated Program Cost: $3,306
Gainful Employment Disclosure
- Must be 18 years of age
- Official high school or GED transcript is required to apply
- Achievement of minimum program admission scores in Reading, English, and Math
- Transfer of previous post-secondary credits will be determined by the registrar.
Student Performance/Graduation Requirements: Students must maintain a 2.0 grade point average and complete all required courses to graduate.
EMPLOYMENT OPPORTUNITIES: Graduates may work in governmental positions during regulatory monitoring and enforcement while others may work in private industry on the compliance side of the assurance field.
SALARY POTENTIAL: Minimum: $32,000
PROGRAM ADDITIONAL FEES (Cost are estimated and are subject to change): Books & Supplies: $1,500.00 and Uniform:$100.00
As set forth in its student catalog, Atlanta Technical College does not discriminate on the basis of race, color, national or ethnic origin, gender, religion, disability, age, political affiliation or belief, veteran status, or citizenship status (except in those special circumstances permitted or mandated by law). For further information regarding these laws (Title VI and IX) contact Sylvie Moses, equity/special needs coordinator, Atlanta Technical College, Cleveland Dennard Center, suite B164, 404.225.4434. Email: firstname.lastname@example.org. To request reasonable accommodations upon enrollment (Section 504/ADA), contact Sylvie Moses, career planner/special needs, student affairs division, Cleveland Dennard Building, suite B164, 404.225.4434. Email: email@example.com. Atlanta Technical College, 1560 Metropolitan Parkway, SW, Atlanta, GA 30310.
Blood and Airborne Pathogens: Students enrolled in Category I and II programs at Atlanta Technical College will be performing tasks in which there is a normal occurrence for exposure to blood, other potentially infectious body materials, and airborne pathogens. These tasks will be performed in the classroom, laboratory, and clinical activities for each occupational training program/course. Students will be required to present documentation of Hepatitis B and Tuberculosis immunizations as a result of potential occupational exposure. Students should contact their program directors for more information. Policies and procedures regarding blood and airborne pathogens may be reviewed at www.tcsg.org/tcsgpolicy/menu.html.
Currciulum (24 hours)
General Education Courses (9 hours)
Introduces chemical concept principles, laws, and techniques applicable to the medical laboratory. Topics include laboratory safety, fundamental principles of chemistry, weight and measures, solutions, and basic laws of chemistry.
Provides an introduction to basic biological concepts with a focus on living cells. Topics include chemical principles related to cells, cell structure and function, energy and metabolism, cell division, protein synthesis, genetics, and biotechnology.
Selected laboratory exercises paralleling the topics in BIOL 1111. The laboratory exercises for this course include chemical principles related to cells, cell structure and function, energy and metabolism, cell division, protein synthesis, genetics, and biotechnology.
Emphasizes the application of basic mathematical skills used in the solution of occupational and technical problems. Topics include fractions, decimals, percents, ratios and proportions, measurement and conversion, formula manipulation, technical applications, and basic statistics.
Occupational Courses (15 hours)
Introduction to and survey of the broad range of activities in bioscience technology. Major applications and advances in pharmaceuticals, medical devices, genomics, forensics, proteomics, agriculture, and environmental science will be covered. Including an in depth examination and discussion of ethical, legal and hands-on activities based on authentic bioscience applications. There is a survey of technical and regulatory aspects of physical, chemical, radiation and biological safety in the bioscience laboratory.
An introduction to the basic concepts of federal regulation of bioscience/ biotechnology research and biomanufacturing. The structure and purview of the U.S. Food and Drug Administration, U.S. Department of Agriculture, Environmental Protection Agency and Occupation Safety and Health Administration will be covered. This course will also focus on the regulation of product produced in the life science sector including strategic planning, compliance, validation and documentation of production. Students will gain an understanding of the role of regulatory affairs in the overall business scheme. Differences between the regulatory requirements of the U.S. market compared to the European and Asian markets will be examined.
This course provides an overview of documentation and validation concepts used within a biomanufacturing facility. Emphasis will be placed on source documentation, writing and executing Standard Operating Procedures (SOPs), process and equipment validation, as well as validation of bulk starting materials. A hands-on laboratory-based course that will familiarize students with some basic procedures and techniques common to laboratories involved with work that is covered by Quality Systems Regulation (QSR) and current Good Manufacturing Practices (cGMP). The principles of Good Laboratory Practices (GLP) and effective documentation procedures will be stressed.
This course is an introduction to the steps of development of products produced by microorganisms using biotechnology and genetic engineering which include; biopharmaceuticals, vaccines, enzymes and food ingredients. It will also introduce the various career opportunities involved in bioprocessing. Lectures will emphasize: how genetically altered microorganisms are used in drug development, methods used for manufacturing of biopharmaceuticals, vaccines, enzymes and food ingredients, biopharmaceutical process development, the design of biomanufacturing equipment and facilities, how bioprocesses are regulated by the U.S. Food and Drug Administration (FDA regulatory compliance), an introduction to bionanomaterials, and an introduction to scientific, engineering, regulatory compliance and business careers in biomanufacturing.
Introduces the fundamental concepts, terminology, and operations necessary to use computers. Emphasis is placed on basic functions and familiarity with computer use. Topics include an introduction to computer terminology, the Windows environment, Internet and email, word processing software, spreadsheet software, database software, and presentation software.