Projects are designed to allow for a concentration on your area of professional focus and relate it to the
regulatory agency(-ies) that are most relevant to this area. It is designed to help you gain a better
understanding of these agencies and what types of interactions might be necessary in your current or future
role. Write a paper focusing on the regulatory and quality aspects of the problem of your choosing as
described below, addressing the topics of this outline.
Project
Begin with the Federal Regulatory Directory textbook “Thematic Table of Contents”. Find a regulatory
grouping most relevant to your area of concentration. For those in a science curriculum (as is the focus of the
Science Management and Leadership Program), the most apparent relevant science-related regulatory
groupings are:
Agriculture
Energy
Environment & Natural Resources
Health, Safety, and Nutrition
Law and Justice
Science, Technology, and Communications
Others might also be relevant to your area, and can be used, if appropriate, for your project.
Identify regulatory and quality aspects within the department of Veterans affairs health care system
Write a paper focusing on the regulatory and quality aspects of the problem chosen. Since this course is
designed to heighten your awareness of regulatory and quality affairs, the project paper is intended to test
your ability to apply the knowledge you have gained. Thus, the paper should focus on the following areas that
are pertinent to regulatory and quality concepts:
Item
Question
Focus Area of the Paper
5/10/2020 Writers Hub – Freelance Writing
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Defining the project topic
Define within your subject area an appropriate pertinent problem or exercise that has a strong
regulatory/quality component. For example, submitting a medical device to the Food and Drug
Administration (FDA) for clearance or approval to commercialize the device, or getting a manufacturing
process approval by the Environmental Protection Agency relative to waste disposal.
Project management
Define how you would approach the regulatory and quality components from a project management
perspective.
Regulatory agencies affected
Define what regulatory agency or agencies within the grouping chosen are most applicable and why. Give a
brief summary of the operations of these agencies.
Agency interactions
Outline your necessary interactions with these agencies relative to your project topic, and how they are
relevant during the planning, execution, and following completion of the problem and/or exercise that forms
the basis for your project paper. For example, submissions to the agencies that might be necessary, agency
reviews and inspections that might take place, post- or ongoing activity monitoring that might result due to
agency requirements.
Quality Systems
Outline relevant Quality System parameters and considerations that ensure the integration of quality into your
product(s)/service(s)/operation(s) and the continuation of compliance and quality in ongoing activities.
Risks
Identify and describe the risks, risk management, and initial and ongoing risk control associated with your
problem and/or exercise.