Syllabus for MRA 603: Medical Device and Pharmaceuti
| Course: | MRA 603 - Medical Device and Pharmaceuti |
| Lead Faculty | Mr. Irvin Kluth |
| Last revised: | Date: March 17, 2009 By: Mr. Irvin Kluth |
| Textbook: | For the correct edition of the textbook assigned to a specific class, go to: http://www.nutextdirect.com |
| Course Description: This course will focus on the laws and regulations, documentations and process imposed by the Federal government especially the Food and Drug Administration related to pharmaceutical and medical device approval. The course will provide students with detailed knowledge and practical application as it applies to appropriate documentation and process of approval for pharmaceutical and medical devices. The students will understand the nomenclature of the regulatory agencies; have a thorough knowledge of the code of Federal Regulations as it applies to medical devices and pharmaceutical products. | |
Course Learning Outcomes:
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Recommended Course Grading (expressed as percentages):
| A | 96-100 | B+ | 87-89 | C+ | 77-79 | D+ | 67-69 |
| A- | 90-95 | B | 84-86 | C | 74-76 | D | 64-66 |
| B- | 80-83 | C- | 70-73 | D- | 60-63 |
Grading Factors:
Each instructor is responsible for identifying several specific grading components and the weight to be assigned to each component. The following are examples only, and are not meant to be all inclusive:
Definition of Grades:
| Undergraduate Courses | ||
| A | Outstanding Achievement | Significantly exceeds standards |
| B | Commendable Achievement | Exceeds standards |
| C | Acceptable Achievement | Meets standards |
| D | Marginal Achievement | Below standards |
| F | Failing * | |
| Graduate Courses | |
| A | Outstanding Achievement |
| B | Commendable Achievement |
| C | Marginal Achievement |
| D | Unsatisfactory * |
| F | Failing * |
* Students receiving this grade in a course that is required for his/her degree program must repeat the course.
| I | Incomplete A grade given at the discretion of the instructor when a student who has completed at least two-thirds of the course class sessions and is unable to complete the requirements of the course because of uncontrollable and unforeseen circumstances. The student must convey these circumstances (preferably in writing) to the instructor prior to the final day of the course. If an instructor decides that an "Incomplete" is warranted, the instructor must convey the conditions for removal of the "Incomplete" to the student in writing. A copy must also be placed on file with the Office of the Registrar until the "Incomplete" is removed or the time limit for removal has passed. An "Incomplete" is not assigned when the only way the student could make up the work would be to attend a major portion of the class when next offered. An "I" that is not removed within the stipulated time becomes an "F." No grade points are assigned. The "F" is calculated in the grade point average. |
| W | Withdrawal Signifies that a student has withdrawn from a course after beginning the third class session. Students who wish to withdraw must notify their admissions advisor before the beginning of the sixth class session in the case of graduate courses, or before the seventh class session in the case of undergraduate courses. Instructors are not authorized to issue a "W" grade. |
Plagiarism:
Plagiarism is the presentation of someone else's ideas or work as one's own. Students must give credit for any information that is not either the result of original research or common knowledge. If a student borrows ideas or information from another author, he/she must acknowledge the author in the body of the text and on the reference page. Students found plagiarizing are subject to the penalties outlined in the Policies and Procedures section of the University Catalog, which may include a failing grade for the work in question or for the entire course. The following is one of many websites that provide helpful information concerning plagiarism for both students and faculty: http://www.indiana.edu/~wts/pamphlets/plagiarism.shtml
Ethics:
Ethical behavior in the classroom is required of every student. The course will identify ethical policies and practices relevant to course topics.
Technology:
Students are expected to be competent in using current technology appropriate for this discipline. Such technology may include word processing, spreadsheet, and presentation software. Use of the internet and e-mail may also be required.
Diversity:
Learning to work with and value diversity is essential in every class. Students are expected to exhibit an appreciation for multinational and gender diversity in the classroom.
Civility:
As a diverse community of learners, students must strive to work together in a setting of civility, tolerance, and respect for each other and for the instructor. Rules of classroom behavior (which apply to online as well as onsite courses) include but are not limited to the following:
Students with Disabilities:
Students seeking special accommodations due to a disability must submit an application with supporting documentation, as explained under this subject heading in the General Catalog. Instructors are required to provide such accommodations if they receive written notification from the University.
Writing Across the Curriculum:
Students are expected to demonstrate writing skills in describing, analyzing and evaluating ideas and experiences. Written reports and research papers must follow specific standards regarding citations of an author's work within the text and references at the end of the paper. Students are encouraged to use the services of the University's Writing Center when preparing materials.
The following website provides information on APA, MLA, and other writing and citation styles that may be required for term papers and the like: http://library.nu.edu/FindResources/ReferenceTools/citations.html
National University Library:
National University Library supports academic rigor and student academic success by providing access to scholarly books and journals both electronically and in hard copy. Print materials may be accessed at the Library in San Diego or through document delivery for online and regional students. Librarians are available to provide training, reference assistance, and mentoring at the San Diego Library and virtually for online or regional students. Please take advantage of Library resources:
URL: http://library.nu.edu.
Contact the Library:
Use the Library Training Tools (on the Library Homepage) for additional help