Editorially Revised 3-22-06
University Curriculum Committee
Course Proposal Form
for Courses Numbered 0001 – 4999
(Faculty Senate Resolution #04–18, April 2004)
Note: Before completing this form, please read the accompanying instructions
carefully.
1. Course Prefix and Number:
BIOE 4000
2. Date:
10/12/06
3. Requested Action (check only one box):
X
New Course
Revision of Active Course
Revision & Unbanking of a Banked Course
Renumbering of an Existing Course
from # 3500
to
# 4000
4. Justification for new course or course revision or renumbering:
This curriculum change is a part of a revision of the engineering program to
achieve several goals: 1) more closely align content with general engineering
programs; 2) adjust the timing and coverage of materials to support success in
the fundamentals of engineering exam; 3) adjust the sequence of science,
mathematics, and engineering courses to better integrate the content. These
changes have been developed and approved by the department faculty and
have been endorsed by the Engineering Advisory Board.
5. Course description exactly as it should appear in the next catalog:
4000. Bioprocess Validation and Quality Engineering (4) (F) 4 lecture hours per week. P: ICEE
2060, Consent of Instructor. Overview of bioprocess validation and quality control systems that ensure
safe products, reduce the risk of adverse reactions, and avoid recalls. Emphasizes cost effectiveness
and level of validation required for different phases of development, license application, and process
improvements. Also covers design of experiments in bioprocess applications.
6. If this is a course revision, briefly describe the requested change:
The course number was changed from 3500 to 4000 to align with the timing of
the course as well as its alignment with ICEE 4000. The credit hours for this
course were increased from 3 to 4 due to the inclusion of additional material on
design of experiments, a content addition that is noted in the course
description. Also, prerequisites were modified and include the consent of the
instructor so that as needed or desired by a student, engineering majors from
any concentration can take this course in lieu of ICEE 4000.
2
7. Undergraduate Catalog Page Number from current undergraduate catalog:
296
8. The Writing Across the Curriculum Committee must approve Writing Intensive
(WI) credit for all courses prior to their consideration by the UCC. If WI credit is
requested, has this course been approved for Writing Intensive (WI) credit?
Yes
No
If Yes, will all sections be Writing Intensive (yes/no)?
Yes
No
9. Any course requesting Foundations Curriculum credit must be
reviewed by Academic Standards Committee prior to their consideration by
the UCC. If FC credit has been approved by the ASC, then check the
appropriate box (check at most one), otherwise leave all boxes blank.
English (EN)
Humanities (HU)
Fine Arts (FA)
Health (HL)
10. Course Credit:
Lecture
4
Hours
Science (SC)
Social Science (SO)
Mathematics (MA)
Exercise (EX)
Per
Term
Per
Lab
Weekly OR
Term
Per
Studio
Weekly OR
Term
Per
Practicum
Weekly OR
Term
Per
Internship
Weekly OR
Term
Other (e.g., independent study) Please explain.
Weekly
OR
Credit
Hours
Credit
Hours
Credit
Hours
Credit
Hours
Credit
Hours
4
Total Credit Hours 4
11. Anticipated yearly student enrollment: 25
s.h.
s.h.
s.h.
s.h.
s.h.
s.h.
3
12. Affected Degrees or Academic Programs:
Current
Degree(s)/Course(s)
Catalog Page
BS Engineering
295
13.
Changes in Degree Hours
None
Overlap or Duplication with Affected Units or Programs:
Not Applicable
X
Applicable (notification and responses from affected units are
attached)
14. Approval by the Council for Teacher Education (required for courses affecting
teacher education programs):
X
Not Applicable
Applicable (CTE has given its approval.)
15.
Statements of Support:
X
Current staff is adequate
Additional staff is needed (describe needs in the box below):
X
Current facilities are adequate
Additional facilities are needed (describe needs in the box below):
X
Initial library resources are adequate
Initial resources are needed (in the box below, give a brief
explanation and an estimate for the cost of acquisition of required
initial resources):
X
Unit computer resources are adequate
Additional unit computer resources are needed (in the box below,
give a brief explanation and an estimate for the cost of acquisition):
X
ITCS resources are not needed
4
The following ITCS resources are needed (put a check beside each
need):
Mainframe computer system
Statistical services
Network connections
Computer lab for students
Remember to forward email approval from the director of ITCS to
UCC.
16. Syllabus – please insert course syllabus below. You must include (a) the
name of the textbook chosen for the course, (b) the course objectives, (c) the
course content outline, and (d) the course assignments and grading plan.
BIOE 4000 Bioprocess Validation and Quality Engineering
Required Text:
McCormick, K. (2002). Quality. Oxford: Elsevier Butterworth-Heinemann.
Course Objectives:
Upon completion of this course each student will demonstrate:
 Application of FDA and good manufacturing practices to bioprocess manufacturing
 Ability to plan implementation of a quality system
 Analytical skills to analyze and implement a validation system
 Capability to statistically test system reliability
 Ability to analyze legal and ethical issues of process validation
 Application of methods of design of experiments
Course Outline:
Topics covered in this course include:
 Quality Life Cycle
 Research and development
 Good Manufacturing Practice (GMP), Good Distribution Practice (GDP),
 Good Laboratory Practice (GLP), Good Clinical Practice (GCP)
 Drug Registration in the European Union and the US
 Responsibilities of and Relationships between Quality Management, QA, GMP and QC
 ISO 9000 Series, ISO 14000 Series
 Use of the Quality Systems Approach within the Pharmaceutical Industry
 The Quality Management System
 The Cost of Quality
 Technology Transfer and Validation
 Design of Experiments and Qualification
 Calibration
 Auditing/Inspections/Auditing
 Sterile manufacturing
 Validation and environmental monitoring
 Design of water treatment systems
 Quality Improvement Programs
5

Quality Tools and Techniques
Student Assessment:
Students will be evaluated based on a combination of class activities (see below). The final grade will be
assessed with the following criteria:
A
B
C
D
F
Grading
90% or better
80% or better
70% or better
60% or better
Less than 60%
Assessment
Quizzes
Exams
Case Studies
Projects
Total
10 %
45 %
30 %
15 %
100%