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BIO
499 |
| California State
Polytechnic University, Pomona |
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Instructor:
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Dr.
Wei-Jen Lin
bldg 4, Rm 3-760 (Office) 909-869-4179 (tel); weijenlin@csupomona.edu http://www.csupomona.edu/~weijenlin; click on Bio499 |
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Lecture:
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T
Th 4-4:50 pm, Rm 4-2-529
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Lab:
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T
Th1-3:50 pm, Rm 4-2-529
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Office
Hours:
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T
Th 10:20 am - 12 pm; W 1 - 2:40 pm; Additional hours by appointment
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Web resource:
FDA - Food and
Drug Administration
FDA Compliance Program
- Guidance Manual for FDA inspection
eCFR - Search and retrieve Code of Federal Regulations
CFR
title 21 - CFR related to Food and Drug Administration
Clinical Trial Search
BIO - Biotechnology
Industry Organization
PhRMA - Organization for leading research-based
pharmaceutical and biotechnology companies
Biotechnology glossary
Career in
Biotechnology/Pharmaceutical companies - job descriptions, salary ranges,
etc.
SOP
instruction
US
Biotechnology Report 2003 - by Department of Commerce
| Selected
Company profiles |
Method
Compendia and Standards |
Course description:
This is a laboratory-based course that provides students with the opportunity
to learn laboratory skills commonly used in the biotech/pharmaceutical industry.
These skills include data recording, project management, and the use of the
US Pharmacopeia protocols for microbial and chemical testing of pharmaceuticals.
Regulations and documentation requirements along with good laboratory practices
and good manufacturing practices will be incorporated.
Prerequisites:
MIC201 and CHM221; or with the consent from the instructor
Textbook and
reading
There is no textbook that covers these topics. The instructor will provide handouts
for lectures. Lab manual is available at the CopyNmail center.
Who would benefit
from the course:
For those who 1) would like to work in the industry, 2) will oversee laboratory
operation (e.g. FDA investigator, project manager); or 3) would like to work
on projects to enhance laboratory and critical thinking skills.
Class Requirements
Attendance is assumed. Students are responsible for lecture and laboratory
materials missed in their absence. Missed laboratories cannot be made up. Missed
exams may be made up only if the instructor has been informed of the absence
and found the excuse acceptable before the exam. Students are expected to participate
in field trips during or beyond the class hours.
Examination
and Grade Determination (tentative)
Bi-weekly quizzes and one final exam are scheduled. Exams will be multiple
choices and short answers. Team project will be described later. The lecture
and lab will be graded together.
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Points
|
%
of total points
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Grade
|
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| Quizzes |
100
|
90-100%
|
A
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| Final exam |
100
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80-90%
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B
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| Lab notebook/assignments |
100
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65-80%
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C
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| Team project/report |
200
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50-64%
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D
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| Total points |
500
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Tentative Course and Lab Outline