BioNetwork Capstone Center
Course
Fall Course Schedule 2011
(Section #) Cost
Date/Days/Time
Instructor
August
Operations in Biotechnology Processes
(73766) $120
29-Sept 2
Take a hands-on approach to learning the details of the typical processing steps
used to produce a biopharmaceutical in a simulated cGMP environment. An
understanding of the science and equipment used in each processing step will be
provided, as well as hands-on laboratory experience in fermentation, product
isolation, and purification of a protein.
Elements of Current Good Manufacturing
(75740)
$65
12-15
MTWTh
F
8am-5pm
8am- noon
September
MTWTh
6pm-10pm
David Yarley
Expand your knowledge in the application of current good manufacturing practices
(cGMP) in the production of biopharmaceuticals. An overview of topics will be
covered from current regulations found in the selections of 210/211 of Title 21 of
the Code of Federal Regulations (CFR) as well as the relevant I CH and FDA
guidance documents.
Gowning Certification
(75779)
$65 19
M
8am-4pm
Tim Miller
MTWTh
8am-5pm
David Yarley
F
S
9am-5pm
9am-3pm
Robert Crosby
MTWTh
8am-6pm
Rebel Umphlett
A classroom component will address the requirements and science behind aseptic
gowning; followed by a practice gowning lab. Once the gowning practice is
complete, each student will need to complete three consecutive successful
gowning events on three separate days to earn the certification. The gowning
attempts are to be individually scheduled with the aseptic processing instructors,
and may be interspersed with other classes. This certificate is comparable to
gowning certifications within the industry.
Fermentation Processes
(73767) $120
19-22
Learn the fundamentals of fermentation technology and processes in the chemical
and biotechnology industries. Labs provide hands-on experience with the
fermentation process equipment typically used in industry. The focus is primarily
microbial fermentation but includes some aspects of mammalian cell culture.
HPLC in Theory and Practice
(73769)
$65 23
24
Learn about HPLC (High Performance Liquid Chromatography), a chemistry
technique used to separate chemical compounds-of-interest from other
compounds in a liquid sample. Topics will include an introduction to separation
science and detection methods, types of HPLC, instrument orientation, operation,
maintenance, and troubleshooting, as well as sample preparation and analysis.
Laboratories will provide hands-on experience.
Elements of Aseptic Manufacturing I
(73768) $120
Practice the basics of clean room operations in a certified, cGMP environment.
Topics will include basic microbiology, clean room design and control,
environmental monitoring, glassware and equipment preparation, solution
processing (compounding), and filtration.
26-29
Course
Cell Culture Processes
(Section #) Cost
(73771) $120
Date/Days/Time
3-6
October
MTWTh
10-14
MTWThF
31-Nov. 3
8am-5pm
Build on the fundamentals of bioprocessing as taught in the Capstone course
Operations of Biotechnology Processes. Mammalian systems are discussed, and
other industrially relevant systems briefly introduced. Labs provide hands-on
experience in culturing mammalian cells, including operation of the instrumentation
and lab equipment typical for biotechnology industrial processes related to
mammalian cell growth.
Introduction to Biomolecules
(73985) $65
Instructor
Lourdes Bermejo and
David Yarley
6pm-10pm
Dr. Mike Morgan
MTWTh
8am-6pm
Rebel Umphlett
1
November
T
8am-5pm
Dr. Mike Morgan
1&3
TTh
Biomolecules are often the end product and a critical component of the
bioprocessing and biopharmaceutical industries. This course provides a basic
introduction to inorganic and organic chemistry followed by a discussion of the
structure, function, and behavior of the four groups of biomolecules
(carbohydrates, lipids, nucleic acids, and proteins). This course may be particularly
useful to those with limited formal education in inorganic chemistry, organic
chemistry, and biochemistry. The class format consists of lectures and classroom
exercises but does not contain a laboratory component.
Elements of Aseptic Manufacturing II
(73816) $120
Delve into the Aseptic Processing arena with intensive hands-on instruction of
aseptic techniques in a simulated cGMP environment. Instruction includes process
simulations of filtrations, hand filling, semi-automated filling, release testing of final
product and deviation investigations. Topics of classroom instruction include FDA
regulations pertaining to Process Simulations, review of microbiology, water
system review, and investigational technique. Either completion of Aseptic
Manufacturing Level 1 or at least 2 years of clean room experience are
recommended.
Micropipetting for Precision & Accuracy
(73819)
$65
Learn the principles of Micropipetting used in the biotech/biopharma and other
laboratory settings. Individual student pipetting skills will be pre-assessed, followed
by lessons that focus on individual improvement. This course is a must for anyone
who uses pipettes for accuracy and precision.
Good Laboratory Practices
(73823)
$65
Develop an understanding of the documentation guidelines required for the
generation of acceptable EPA and FDA product registration safety studies. A
series of exercises, including a labeling exercise, a protocol review, and adherence
to SOPs, reinforce course concepts.
6pm-10pm
Dr. Gerald Picard
Course
(Section #) Cost
Preparation & Purification of Biological Samples
for HPLC Analysis
(73826)
Date/Days/Time
November continued
Instructor
5, 12, 19
S
8am-5pm Dr. Gerald Picard
7-11
MTWTh
F
8am-5pm
8am-noon
Dr. Michael Morgan
14-17
MTWTh
8am-5pm
David Yarley
21, 22
MT
8am-5pm
David Yarley
$65
Learn sample preparation and purification techniques used in HPLC determination
of trace levels of organic compounds such as drug and pesticide residues in
biological samples. The lectures will cover techniques employed for obtaining
representative samples, sample extraction and purification techniques, including
solid-phase extraction and liquid-liquid partitioning, as well as basic analytical
approaches and instruments (HPLC) used in trace organic analysis. Laboratory
sessions provide hands-on experience reflective of techniques discussed in
lecture.
Industrial Microbiology
(74208) $120
Develop an understanding of how various microbiological tests are applied to a
wide range of products regulated by the FDA or similar agencies. The concepts of
microbial detection, isolation, quantification (enumeration), and identification are
discussed. An introduction is presented to the most commonly tested groups of
microbial contaminants, bacteria and fungi. Laboratory exercises are designed to
provide practical experience in basic microbiological procedures that are
commonly encountered in an industrial microbiology laboratory.
Chromatography in Theory & Practice
(73827) $120
Chromatography is a critical operational step in many pharmaceutical downstream
processes. This course presents lectures of the equipment and the most
commonly used types of chromatography. The lab will introduce two types of
chromatography through hands-on exercises.
Elements of Current Good Manufacturing
(73828)
$65
Expand your knowledge in the application of current good manufacturing practices
(cGMP) in the production of biopharmaceuticals. An overview of topics will be
covered from current regulations found in the selections of 210/211 of Title 21 of
the Code of Federal Regulations (CFR) as well as the relevant I CH and FDA
guidance documents.
HPLC in Theory & Practice
(73995)
$65 3, 10
December
S
8am-5pm Dr. Gerald Picard
Learn about HPLC (High Performance Liquid Chromatography), a chemistry
technique used to separate chemical compounds-of-interest from other
compounds in a liquid sample. Topics will include an introduction to separation
science and detection methods, types of HPLC, instrument orientation, operation,
maintenance, and troubleshooting, as well as sample preparation and analysis.
Laboratories will provide hands-on experience.
Good Laboratory Practice
(74287)
$65
Develop an understanding of the documentation guidelines required for the
generation of acceptable EPA and FDA product registration safety studies. A
series of exercises, including a labeling exercise, a protocol review, and adherence
to SOPs, reinforce course concepts.
6, 8
TTh
6pm-10pm Dr. Gerald Picard
Course
(Section #) Cost
Gas Chromatography-Fatty Acid Methyl Ester
(GC-FAME) Analysis for Microbial Identification
Date/Days/Time
December continued
6-8
TWTh
(74212)
8am-5pm
Instructor
Dr. Mike Morgan
$65
This course focuses on Gas Chromatography-Fatty Acid Methyl Ester (GC-FAME)
analyses for quick and accurate identification of bacterial and yeast isolates, for
work in pharmaceutical and other FDA-regulated industries. Lectures will address
the biochemistry of GC-FAME analysis and the instrumentation used, and
laboratory sessions will provide hands-on experience.
Elements of Current Good Manufacturing
(73994) $65
12-15
MTWTh
6pm-10pm
David Yarley
Expand your knowledge in the application of current good manufacturing practices
(cGMP) in the production of biopharmaceuticals. An overview of topics will be
covered from current regulations found in the selections of 210/211 of Title 21 of
the Code of Federal Regulations (CFR) as well as the relevant I CH and FDA
guidance documents.
Preparation & Purification in Theory & Practice
of Biological Samples for HPLC Analysis
14-16
WThF
8am-5pm
Dr. Gerald Picard
(74225) $65
Learn sample preparation and purification techniques used in HPLC determination
of trace levels of organic compounds such as drug and pesticide residues in
biological samples. The lectures will cover techniques employed for obtaining
representative samples, sample extraction and purification techniques, including
solid-phase extraction and liquid-liquid partitioning, as well as basic analytical
approaches and instruments (HPLC) used in trace organic analysis. Laboratory
sessions provide hands-on experience reflective of techniques discussed in
lecture.
To register, go to www.waketech.edu, click on “Take Classes”, then “Continuing Education”, or call 515-0232.