Computer Systems Validation in Regulatory Affairs

PROGRAM OVERVIEW

The MS in Computer Systems Validation in Regulatory Affairs program consists of 30 graduate-level semester credit hours, of which 15 are foundation, 12 are concentration, and 3 are elective (including the option coursework, project, or internship). A concentration must be declared by admitted students. The program includes 4 concentrations: (1) Concepts of Validation in Pharmaceutical Industry, (2) Regulatory Affairs in Pharmaceutical Industry, (3) Regulatory Compliance for Computer Systems in the Pharmaceutical Industry, and (4) 21 CFR part 820 and ISO 13485 Regulations. Students must choose one of three options: coursework, MS project, or Internship. The program may be completed entirely on campus, or through a combination of on-campus and online courses.

PROGRAM OBJECTIVES

The objective of the program is to prepare IT professionals to gain a comprehensive understanding of Computer System Validation (CSV), its significance in regulated industries, and the associated regulations and standards and the skills necessary to effectively manage electronic data in a regulated environment while ensuring compliance with regulatory guideline such as FDA’s 21 CFR Part 11 and EU Annex 11. Graduates will earn a Master of Science degree with a major in Computer Systems Validation in Regulatory Affairs and this area of concentration recognizes that all IT professionals, regardless of position, can be called on to serve in regulatory affairs roles. As we look forward to the increasing use of artificial intelligence, we will require increasingly sophisticated computers, trained users, skilled IT professionals, and involved management. This program is designed to produce graduates who are highly qualified to manage US and Global Regulatory Process for companies innovating and developing cutting-edge products in Life Sciences.

CREDIT FOR PRIOR LEARNING

Students may earn up to six (6) semester credits, not exceeding 20% of the program, for prior learning that is equivalent in content and rigor to MS CSVRA courses. Credit may be granted based on official transcripts, verified work experience, or professional certifications and must be approved by qualified faculty and/or admissions department. Such credits are recorded as “Credit for Prior Learning,” carry no letter grade, are excluded from GPA calculation, and do not reduce the minimum in-residence coursework required for degree completion.

DEGREE OUTCOMES

Successful completion of the MS-CSV Program will enable students to:

Understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle.
Examine quality systems and standards and their impact on product and public safety as well as the importance of quality products from the perspective of healthcare providers.
Manage the product life cycles of biopharmaceutical and medical devices from conception through launch to obsolescence.
Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures.
Recognize the factors that influence domestic and international regulatory decisions.
Understand the policies and procedures needed to support the validation process and ongoing maintenance of systems in a validated state.
Know how to best prepare for an FDA inspection or audit of a GxP computer system.

CAREER OPTIONS

Career options may require additional experience, training, or other factors beyond the successful completion of this program. A Master of Computer Systems Validation in Regulatory Affairs degree can academically prepare you to pursue career options such as:

WORK SETTINGS

A Master of Computer Systems Validation in Regulatory Affairs degree can academically prepare you to work in settings such as:

PROGRAM ADMISSION REQUIREMENTS

Completed Graduate Admissions Application and Application Fee of $50.
Bachelor’s degree in a related field from an accredited college or university in the United States or degree equivalent to a U.S. bachelor’s degree (outside U.S.) i.e. Bachelor’s degree in Computer Science / Electronics / Mechanical / IT, Pharmacy, Biology, Chemistry, Physics, Therapy, Engineering, Health Law, Health Policy, Home Sciences, Life-Sciences (Microbiology, Biochemistry, Biotechnology, Bioinformatics or related fields), or work experience in related field.
Admission to the program requires a minimum undergraduate cumulative grade-point average of 2.0.
Official transcripts are required. The prospective student must arrange to have an evaluation of your foreign transcript by one of the recognized Education evaluation companies. The cost for foreign transcript evaluation is the responsibility of the student.
Professional Resume.
Two letters of recommendation.
Statement of Purpose.
GRE optional.
Proof of English Language Proficiency (TOEFL/IELTS/PTE/Duolingo Score Report). Non-native English speakers who did not complete post-secondary education exclusively in the English language must provide proof of English language proficiency.
Proof of funds.

PROGRAM OUTLINE

The MS in Computer Systems Validation in Regulatory Affairs requires completion of the following 30 credit hours

Foundation courses: 15 credits
Concentration courses: 12 credits
Elective courses: 3 credits

FOUNDATION COURSES:

MS 610: Foundations of Technology and Artificial Intelligence
MS 620: Database Management
MS 630: Quality Assurance
MS 640: Business Analytics
MS 650: Software Development Life Cycle

CONCENTRATION COURSES:

CSV 720: Concepts of Validation in the Pharmaceutical Industry
CSV 730: Regulatory Affairs in the Pharmaceutical Industry
CSV 740: Regulatory Compliance for Computer Systems in the Pharmaceutical Industry
CSV 750: 21 CFR part 820 && ISO 13485 Regulations

ELECTIVE COURSES: Choose One course from the following Three courses

MS 770: Data Mining
MS 790: Internship
CSV 790: Capstone Project