Master of Science in Quality Assurance and Regulatory Science
Offered in Partnership with the Department of Chemistry, Judd A. and Marjorie Weinberg College of Arts and Sciences, Northwestern University
Science and technology are moving at an increasingly rapid pace, with pressure
on industry to get new products to market swiftly while assuring consumers
and regulatory agencies that these products are effective and safe. The food,
pharmaceutical, and biotechnology industries are challenged to develop processes
and procedures to ensure that products meet quality and regulatory standards.
Thus, today's laboratory scientist must possess the knowledge, expertise, and
skills to create and implement efficient and effective quality systems as well
as understand the regulatory and compliance environment. Other essential skills
include project management, risk assessment, and risk management. Efficient
risk management requires developing quality standards, using the best scientific
data, and employing practices that result in clear and consistent decisions
and clear communications with the public and regulatory agencies.
In the MQARS program Northwestern University has created an industry-standard
graduate program in quality and regulatory issues to serve an audience of practicing
scientists in the pharmaceutical, food, and biotechnology industries.
The program's 10-course curriculum is designed to bridge the gap between traditional
academic programming in the life sciences and the quality assurance and regulatory
demands of industry. Scientists holding undergraduate and graduate degrees
in fields such as biology, chemistry, bioengineering, biotechnology, and chemical
engineering routinely find themselves asked to play a leadership role in quality
assurance, yet they are unlikely to have any formal education in this area
or possess current knowledge in this increasingly complex field. Pharmaceutical,
food, medical device, and other similarly regulated industries face many overlapping
quality challenges that are better addressed by a professional master's degree
than by internal training programs.
A five-course graduate certificate is available for quality assurance and regulatory affairs professionals seeking only specific course work.
Please be sure to review the important dates pertaining to this program
Program Outcomes
The objectives of the MQARS program are to:
- provide life scientists in FDA-regulated industries the tools they
need to be leaders in quality assurance and regulatory affairs
- increase
safety and efficiency in crucial industries in areas such as pharmaceuticals,
food, and biomedical
- enhance the skill-set of industry scientists in order
to make them more valuable and flexible and improve their career options
- contribute
to the professionalization of quality and regulatory areas
- prepare students
to transition from the academic to professional demands on life scientists
Learning Outcomes:
Students who complete the MQARS program will have gained the skills and knowledge
to:
- Understand the current regulatory environment for applied life sciences
within a broad global context
- Understand the nature of quality assurance
within regulated industries
- Assess and develop quality and regulatory strategies for specific industries,
including pharmaceutical, biotechnology, and food
- Develop and utilize project
management skills to conduct research and clinical trials as demanded by
regulatory agencies
- Understand and apply principles of risk management and ethical enterprise
compliance
- Create quality assurance processes that support compliance
auditing requirements
- Represent persuasively the role of quality assurance
in spurring innovation throughout an enterprise
Career Opportunities
"As more companies continue to mature and shift their focus from
R&D to product and manufacturing, the demand for individuals with industry-specific
technical, management and team-based problem-solving skills has outpaced
the supply of candidates."
-E. Dale Sevier, et al, Nature
Biotechnology (Nov. 2003)
Graduates with a master's degree in quality assurance and regulatory
science will have an edge when seeking careers in life science and FDA-regulated
industries. In recent years, the FDA has become increasingly diligent in
enforcement of current Good Manufacturing Practices (cGMP) and other areas
of regulation. No company manufacturing products for the food, drug, or
medical device industry can afford to do without highly knowledgeable and
skilled quality systems experts. Those with a scientific background will
augment their value to the industry-and broaden the areas where they
can be employed-with this credential.
A Professional Degree
The MQARS is a professional
degree that explores foundational knowledge and skills in quality and
regulatory areas. In this way, Northwestern University has crafted a program
that develops quality and regulatory experts who can operate outside of
the narrow silos of specific industries or companies. Industry professionals—at
any stage in their careers—will benefit from a curriculum that is
both theoretical and applied. The classroom experience complements the knowledge
base gained on the job and creates a valuable learning network. The two-part
leadership series brings professionals from several industries together
and connects the core of the discipline to best management practices.
In order to accommodate the busy schedules of working professionals, the
MQARS program is ideal for part-time study. Courses are offered at convenient
locations during evening hours over a 10-week quarter. Applications are
accepted four times a year, so students can start and complete the program
while continuing to meet their professional and private demands.
Features of the Program
- 10-unit program that can be completed in two years
- convenient part-time schedule
- cross-industry curriculum, including best management and statistical
practices
- useful to professionals at various stages in their careers
- Northwestern University and industry experts as faculty
- full master of science degree or certificate (Professional Graduate
Series) available
For more information about
the growing field of quality assurance and regulatory
science, visit these sites:
|
