Master of Science in Quality Assurance and Regulatory Science
LEADERS 481-0
( Core Course ) Foundations of Leadership
The purpose of this course is to identify the fundamental leadership behaviors that enable people to excel in their careers, and to help students apply these behaviors to personal and professional success. The course builds from the basic premise that leadership is learned, and looks at the theory and practice of leadership at the individual and organizational level. The course will explore definitions of leadership, the importance of leadership, leadership styles, the role of vision and integrity, the importance of giving and receiving feedback, how to lead change and solve problems, effective teamwork, and communication strategies. The culmination of the class will be a personal leadership development plan formulated by each student. Required for students admitted for fall 06 and after.
Fall 2009
CH
M
7:00 - 9:30 PM
Sec. 50
Wieboldt Hall 406
9/28/09 - 11/30/09
Instructor:
EV
Th
7:00 - 9:30 PM
Sec. 51
Kresge Hall 2410
9/24/09 - 12/3/09
Instructor:
Winter 2010
EV
Sa
9:00 - 11:30 AM
Sec. 50
1/9/10 - 3/13/10
Instructor:
CH
M
7:00 - 9:30 PM
Sec. 51
1/4/10 - 3/15/10
Instructor:
Spring 2010
LP
Tu
7:00 - 9:30 PM
Sec. 50
3/30/10 - 6/1/10
Instructor:
Summer 2010
EV
M
7:00 - 9:30 PM
Sec. 50
6/21/10 - 8/23/10
Instructor:
QARS 401-0
( Core Course ) Regulation and Quality Systems
Introduction to the domestic and global regulatory landscape and essential quality systems governing Food and Drug Administration-regulated industries. Includes a review of the historical context for the creation of the FDA. A cross-industry overview for scientists charged with regulatory affairs and quality assurance responsibilities and of potential value to anyone with managerial duties affecting these areas. Discusses the pivotal role of quality in determining value chains and innovation; compliance with quality systems contained within the Code of Federal Regulations, International Organization for Standards, and International Conference on Harmonization. Prerequisite: none. This class may be taken as an elective for MCRRA.
Fall 2009
EV
M
7:00 - 9:30 PM
Sec. 50
Tech Institute LG76
9/28/09 - 11/30/09
Instructor:
Summer 2010
EV
Days: TBA
Time: TBA
Sec. 50
Dates: TBA
Instructor:
TBA
QARS 405-0
( Core Course ) Applied Research and Writing
This course immerses students in the research, writing, and presentation skills critical for professionals in the field of quality assurance and regulatory science. Course assignments include three key tasks: outlining standard operating procedures, writing responses to audits, and creating visual presentations of technical data. Students practice information gathering, data analysis, logical argument development, effective use of documentation, response diagrams, presentation designs, formal responses to the federal government, and informal communication. Students learn to evaluate the strengths and limitations of various research methods and how to select the best method for a given task. This course provides a foundation for writing academic papers and prepare students for the capstone project. Required for students beginning the program in fall 2008 or later. May be taken as an elective by students who began the program prior to fall 2008. Should be taken as one of the first three courses.Prerequisite: none. This class is a core requirement of both the MQARS and MCRRA degrees.
Winter 2010
EV
Tu
7:00 - 9:30 PM
Sec. 50
1/5/10 - 3/9/10
Instructors:
Summer 2010
EV
Days: TBA
Time: TBA
Sec. 50
Dates: TBA
Instructor:
TBA
QARS 410-0
( Core Course ) Introduction to Statistical Methods for Regulatory Compliance
Emphasis on practical statistical needs for product and process validation for life science industries. Predictive modeling; calibration and specifications development; using statistical software to expedite calculations, applied introductory probability and statistics, including such topics as the binomial and normal distributions, confidence intervals, Student's-t, F, and chi-square tests, linear regression and correlation, and conditional probability; measures of central tendency and dispersion, important discrete and continuous probability distributions, sampling theory, hypothesis testing and estimation. Prerequisite: none. This class is a core requirement of both the MQARS and MCRRA degrees.
The application of statistical methodologies to the analysis and solution of quality and management problems, including hypothesis testing, probability theory, control charts, sampling, multiple regression, and the design of experiments. Focus is on statistical process control and the use of statistics in testing, inspection, and production. Students introduced to National Committee for Clinical Laboratory standards as well as Clinical and Laboratory Institute consensus standards. Topics covered may include validation concepts for plant, process, cleaning, sterilization, filtration, analytical methods, and computer systems; good automated manufacturing practice; Institute of Electrical and Electronic Engineers Software Quality Assurance Plan, new electronic requirements, and relationships to good manufacturing practice; national (FDA) and international (EU) regulatory affairs for quality systems requirements in development and manufacturing. Prerequisite: QARS 410 or consent of instructor.
The course provides an overview of the general principles of managing a quality organization, including methods to evaluate the organization, benchmarking, and the leadership role of the manager. This course also aims to improve effective communication between an organization's staff and quality assurance teams. Specific topics covered include similarities and differences among means of implementing and enforcing regulation, such as current Good Manufacturing Practice, (cGMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), Total Quality Management (TQM), ISO 9001:2000, and Six Sigma quality guidelines for laboratory documentation; standard operating procedures (SOP); reporting, record keeping, and management; preparation and requirements for audits and inspections.Prerequisite: none.
Prior to Fall 2009, this course was titled Practical Laboratory Management.
This course explores quality, standards, and compliance regulations in the laboratory, as well as a review of the laboratory system components that support compliance with quality system regulations and science-based laboratory management. Includes the following specific topics: managing a quality system within an analytical laboratory environment; laboratory certification and accreditation; calibration, qualification, and maintenance of laboratory equipment, review of facility requirements; study of laboratory deviations, failure investigations, and compliance with out-of-specification requirements; test method development, system suitability, and method verification and validation; installation qualification, operational qualification, and performance qualification protocols; notebooks and maintenance logs; training staff and tracking training. Prerequisite: none
An in-depth examination of current theory and techniques in quality assurance project management. Topics include procedures for evaluating overall effectiveness and contribution to production and service quality; effective communications; functions and responsibilities of the quality organization; TQM, Six Sigma, Baldrige Criteria, and ISO concepts; timeline/project management software, and other tools for continuous improvement are analyzed for sequence of use and deployment. Includes validation and auditing. Prerequisite: none. This class may be taken as an elective for MCRRA.
Summer 2010
EV
Days: TBA
Time: TBA
Sec. 50
Dates: TBA
Instructor:
TBA
QARS 430-0
( Core Course ) Ethical and Legal Issues in Regulation and Quality
All regulatory affairs issues are also legal ones, and they are fraught with ethical questions. This course goes beyond reading FDA, Federal Trade Commission, and other rules merely as requirements and challenges students to engage with the complex legal and ethical ramifications of these regulations. Topics include advertising, promotion, and labeling; health and disease prevention claims; dietary supplements; biotechnology labeling issues; intellectual property; the Sarbanes-Oxley Act; conflicts of requirements among different countries and industries; consent and use of samples; criminal liability and enforcement issues. Case studies serve as the primary teaching materials. Prerequisite: none. This class may be taken as an elective for MCRRA.
Winter 2010
EV
Th
7:00 - 9:30 PM
Sec. 50
1/7/10 - 3/11/10
Instructor:
QARS 435-0
( Core Course ) Risk and Decision Management
This course explores theories and practical applications of risk management, risk communication, decision management, and crisis management in life science industries. Topics include failure modes and effects analysis; fault-tree analysis; human factors analysis, and hazard analysis and critical control points. Students learn to anticipate and avoid risk and hazards and manage those that arise in a holistic manner. Prerequisite: none
Spring 2010
EV
Th
7:00 - 9:30 PM
Sec. 50
4/1/10 - 6/3/10
Instructor:
QARS 440-0
( Elective ) Food Quality Assurance
This course provides skills in diagnosing and analyzing problems causing variation in food industry processes. Topics covered include food laws and regulatory agencies, religious specifications (halal, kosher, etc.), organic standards, CFR food safety, allergens, design safety analysis. Prerequisite: QARS 401
No Sections
QARS 450-0
( Elective ) Medical Device Regulations
Analysis of U.S. medical-device development and approval requirements, including regulatory reforms implemented under the Food and Drug Modernization Act, Clinical Laboratory Improvement Amendments, the Center for Devices and Radiological Health reengineering initiatives, and evolving Investigational Device Exemptions; pre-market Approval; 510(k) application process; product development protocol development and review processes. The course also explores emerging developments and trends in medical-device regulation in the United States. Prerequisite: QARS 401 or CLIN_RES 400 or consent of instructor. This class may be taken as an elective for MCRRA.
Winter 2010
EV
Days: TBA
Time: TBA
Sec. 50
Cancelled
Dates: TBA
Instructor:
TBA
QARS 460-0
( Elective ) Drug and Biologics Regulations
Students discuss current policies and guidelines under which pharmaceutical and biological products are developed for human use and regulated while in commerce. Topics include regulatory requirements for patented and generic pharmaceuticals, over-the-counter drugs, and biological products. Students examine the newly implemented steps to harmonize international regulations. Prerequisite: QARS 401 or CLIN_RES 400. This class may be taken as an elective for MCRRA.
Fall 2009
EV
Tu
7:00 - 9:30 PM
Sec. 50
Tech Institute M152
9/22/09 - 11/24/09
Instructors:
QARS 490-0
( Elective ) Special Topics in Regulatory Affairs
Current issues and topics in regulatory affairs are evaluated and discussed. Recent developments and changes in selected areas of regulatory affairs are presented by faculty and industry professionals. May be repeated with new content.
