Quality Assurance and Regulatory Affairs

PCM 550 Technical Writing for Regulatory Affairs

This course reviews regulatory requirements of technical writing in the pharmaceutical/biotechnology industry. Students research, summarize, and organize typical scientific data for issues of content (relevancy, accuracy, balance, and currency), organization, and style. Current FDA and ICH guidelines are addressed. Writing exercises include topics such as developing product label package inserts, and summarizing studies in pharmacokinetics, pharmacodynamics, efficacy and safety, product development, and stability. Specific types of documents that will be addressed will be standard operating procedures, summary of safety and effectiveness, summary of basis of approval, benefit — risk, proposal writing, instructions and manuals, transmittal letters, memoranda, abstracts and summaries, presentations and briefings.

QRA 500 Food, Drug and Cosmetic Act

This course is primarily an introduction to the Food Drug and Cosmetic Act and the regulation of foods, drugs, biologics and devices by the U.S. Food and Drug Administration (FDA). Students will learn the basic statutory and regulatory authorities under which the FDA operates. Because the practice of food, cosmetics biologics and drug law occurs in a rapidly changing technological, legal, and policy environment, this course aims to give the student the ability to keep on top of current trends that they will use and encounter in their profession.

QRA 501 Drug Development: Discovery to Delivery

This course is an overview of product development from discovery through FDA marketing approval. Students will learn the stages of discovery, preclinical, clinical and approvals for drugs, medical devices, and biologics. Students will review the process of development and the interrelationships linking the various disciplines and will be introduced to regulations governing the process, including interactions with FDA, ICH, and other regulatory agencies.

QRA 502 GxP Fundamental: Good Practices in Regulated Industries

This course provides a comprehensive overview of GxP (Good Practice) regulations and their application across regulated industries, including pharmaceuticals, biotechnology, medical devices, and nutraceuticals. Participants will explore the foundational principles behind Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and other GxP domains. Emphasis is placed on global regulatory frameworks such as those from the FDA, EMA, ICH, and WHO. The course includes real-world case studies and compliance strategies to ensure quality, data integrity, and patient safety in regulated environments. This training is ideal for professionals seeking to enhance their understanding of regulatory compliance and implement GxP standards effectively.

QRA 510 Quality Audit

The course covers topics in quality assurance principles, audit techniques, audit types, audit presentation and reports. Audit procedures for GMP and GLP for drugs, biologics, devices, food and cosmetics will be addressed with focus on key areas of inspection readiness and quality systems audits. Students will work with Case studies to simulate a real-world audit using he tools and methodologies learned. Prerequisite(s): QRA 500, 501, and 502 Credit(s): 3

QRA 550 Stat. Analysis for Biotech

This course focuses on equipping students with a comprehensive understanding of statistical concepts and analytical methods for the experimental needs and data encountered in biotechnology. Topics include descriptive statistics, basic probability and random variable theory, sampling theory, statistical inference on one and two samples (confidence intervals and hypothesis testing), categorical analysis, and regression analysis. In addition to the course materials, lecture notes that are prepared using materials from various sources will be used. This course will emphasize the applications pf probability theories and statistical techniques to practical problems relevant to the subject areas of biotechnology. Prerequisite(s): MTH 110 or equivalent, or Program Director Approval Credit(s): 3

QRA 600 Bioethics for Regulated Indust

This course focuses on bioethical issues arising in the regulation and conduct of regulated industries. Students will gain an understanding of bioethics; the theories and principles underlying its practices and application to regulated industries. Students will discuss how bioethical theories and principles provide the foundation for many regulations. Starting with a brief history of ethics and regulation, Students will explore past and present ethical controversies as they pertain to regulated industries. Topics such as genomic editing, cloning, human biological samples, human trials in pandemics, vaccines, animal use and artificial intelligence in these regulated industries will be discussed and analyzed. Credit(s): 3

QRA 601 Global Regulatory Affairs

This course provides a detailed analysis of the regulatory processes for new product approvals in drugs, biologics and medical devices outside of the United States. Students gain experience in comparing the European, Chinese and other regulatory registration trends with those of the United States. Students will explore Stringent Regulatory Authorities (SRA), Brazilian regulatory agency (ANVISA) and the World Health Organization (WHO) program by he analysis of topics such as clinical trials, regulatory intelligence, Drug-device combinations and others. Prerequisite(s): QRA 500 and 501 Credit(s): 3