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Gas Chromatography -
What is Going on Inside the Box?









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Table of Contents

1. Purpose.............................................................................3
2. Student Learning Objectives.............................................3
3. Needs Assessment............................................................3
4. Instructor Guide................................................................4
5. Evaluation Plan..................................................................8
6. Course Syllabus................................................................10
7. Written Assessment.........................................................11
8. Formative Evaluation Questionnaire................................14
9. Summative Evaluation Questionnaire..............................19
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Gas Chromatography What is Going on Inside the Box?

Purpose:
Gas chromatography is a commonly used technique in quality control
laboratories to separate and analyze gasses. This course was created to
satisfy a CAPA (corrective and preventative action) after multiple
investigations were discovered with GC as the root cause of error.

Student Learning Objectives:
Learners should be able to explain the theory behind gas
chromatography.

Learners should be able to recognize and differentiate between
the different parts of the GC.

Learners should be able to outline the process for setting up the
GC.

Learners should be able to investigate and resolve common GC
issues.

Needs Assessment:
The QC laboratory experienced a rash of GC investigations, which
prompted me to perform a needs assessment. I interviewed all
analyzed qualified to run GC in the QC lab. While analysts knew how to
prepare and run samples for GC, they did not understand the theory of
gas chromatography. Analysts also did not know how to effectively
troubleshoot the instrument when issues arise during the analysis. As a
result, the course concentrates on the theory of general
chromatography, the theory of gas chromatography, and how to
troubleshoot the instrument to receive optimal chromatography and
results.
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Instructor Guide
Gas Chromatography What is Going on Inside the Box?

Objectives:
Learners should be able to explain the theory behind gas
chromatography.

Learners should be able to recognize and differentiate between
the different parts of the GC.

Learners should be able to outline the process for setting up the
GC.

Learners should be able to investigate and resolve common GC
issues.

Key Terms:
Chromatography
Gas chromatography
Capillary column
Packed column
Split injection
Splitless injection
Headspace sampler
Flame ionization detector (FID)
Thermal conductivity detector (TCD)
Split peaks
Flat top peaks
Ghost peaks



Discussions:
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How is gas chromatography used in the quality control laboratory?
Gas chromatography is used to quantify chemical compounds used in
the manufacture of pharmaceutical products.

What two phases are used in gas chromatography to elicit separation?
Mobile phase and stationary phase.

What is the difference between split and splitless injectors?
Split injectors vaporize the sample and vent the majority of the sample
to waste; only a small portion of sample enters the column. Splitless
injectors are used to introduce a small amount of sample into the
system without being purged to waste during the injection.

Why are split/splitless injectors used in the QC lab?
The majority of analyses performed in the QC lab uses a capillary
column, smaller injection quantities are needed to prevent overloading
the column.

Activities
Introduction Activity (Slide 3) 10 minutes

Materials Needed:
Flipchart or dry erase board with appropriate marker

Instructions:
Divide classroom into groups of three or four. Each person introduces
him/herself. Next, the group as a whole compiles two to three
questions they would like to have answered in the course. Each group
will select a spokesperson to introduce each person in their group and
share the list of questions they have compiled. Instructor writes all
questions on flipchart or dry erase board to ensure he/she answers all
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relevant questions either throughout the instruction or outside the
class if needed.

Small Group Exercise #1 (After slide #20) 30 minutes

Materials Needed:
Flipchart and marker(s)

Instructions:
This activity involves some creativity in a group setting. To facilitate
better camaraderie between employees, it is preferred to change the
groups so they are different from the introduction activity. Groups of 3-
4 analysts are encouraged.

In this activity, have the groups illustrate the flow of sample through the
GC. They can draw a GC, flow chart, etc. Encourage the analysts to be
creative! After the analysts finish with their drawing, have one
spokesperson present their work of art to the group.

Small Group Exercise #2 (After slide #31) 30 minutes

Materials Needed:
Flipchart and marker(s)
Timer

Instructions:
Divide classroom into two groups. One group will draw a
chromatogram showing a common GC issue (noisy baseline, tailing,
fronting, etc.). The other group has one minute to guess what the issue
is, which grants them one point. If they can say a correct probable
cause of the issue, the group will be granted an extra point. The groups
will take turns drawing and guessing the issue/cause. The group with
the most points at the end of the game ends.

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Evaluation Plan

Formative Evaluation
Formative evaluation is a vital part of instructional design. In this
phase, all course materials are evaluated for limitations in the
instruction so that revisions can be made to the course as necessary.
Since formative evaluation is usually conducted early in the design of
the course, changes can be made early when it's least expensive. I have
chosen to perform one-to-one evaluation to identify any potential
problems in the instruction. The course will be informally assessed by
students, training specialists, subject matter experts, training
supervisors, and the site training manager.
During the development of the course, I received feedback from
three training specialists, a training supervisor, and the training
manager. I created an evaluation form to give employees that
participate in the one-to-one evaluation, which is conducted several
weeks before the class is conducted. The evaluation form evaluates
instructional and cosmetic adequacy. Instructional adequacy addresses
the design, procedures, clarity, and efficiency of the program. Once all
formative evaluations are collected, the evaluation forms will be
reviewed for possible changes. I will divide a sheet of paper into three
columns, Change This Revision, Change Next Revision, and No
Change Required.
Formative evaluation during instruction is another way to ensure
that your course participants understand the content presented.
Changes may be made to the course during the instruction as needed.

Summative Evaluation
Summative evaluations, unlike formative evaluations, are
conducted after the course. Summative evaluations typically assess
effectiveness and efficiency of the course. Summative evaluations are
also designed to determine if the course meets the identified
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instructional needs of the organization. The results of the evaluations
allow the instructor to make suggested changes to the objectives,
content, and course materials as needed. Because summative
evaluations are usually conducted after the course, changes to the
course are harder and more costly compared to changes made as a
result of formative evaluations. I prefer conducting two summative
evaluations one immediately following the course and another
approximately six weeks after the course.
The first evaluation will be conducted immediately after the
course to evaluate the content, instructor, and overall satisfaction with
the course. All responses to the questionnaire are voluntary and
anonymous, which will be conveyed to the class verbally prior to the
evaluation. The survey results will be reviewed with the training
manager prior to successive classes so that changes or improvements to
the course can be made as needed.
The second evaluation will be conducted approximately six weeks
after the course, which will focus primarily on learning transfer.
Hopefully learners have had an opportunity to apply what they have
learned in the course to their job tasks by the time the second
evaluations are conducted. This evaluation will focus on whether or not
the learner believes they gained knowledge as a result of taking the
course. Because a learner's feelings may not be conguent with their
actual performance, I will be monitoring all GC investigations using our
site's event tracking system, TrackWise. I have access to see if learners
were successful in long term learning. As a result of this course, I hope
to observe a smaller number of GC investigations. If there is no
improvement in the number of GC investigations, all course materials
will be reviewed with the training manager to see if there are changes
that can be made to increase learning.
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Gas Chromatography What Goes On Inside the Box?

Instructor:
Stephanie Winstead
QC Training Coordinator
Wilson, NC
Email:

Course Description:
Upon completion of this course, you will understand gas chromatography (GC) theory, how gas
chromatography is used in the pharmaceutical industry, how to analyze samples utilizing gas
chromatography, and how to troubleshoot GCs.

Course Objectives:
Learners should be able to explain the theory behind gas chromatography.

Learners should be able to recognize and differentiate between the different parts of the
GC.

Learners should be able to outline the process for setting up the GC.

Learners should be able to investigate and resolve common GC issues.


Grading:
A written assessment will be administered after the completion of the course. You must score at
least 80% to pass the classroom portion of the course, as per the site training SOP. The
assessment is all multiple choice since the site's learning management system only accepts
multiple choice and true/false questions.

Course Schedule:
15 minutes Introductions, syllabus
20 minutes Chromatography Theory
30 minutes GC Theory
30 minutes Parts of the GC
30 minutes Small group exercise #1 Parts of the GC
30 minutes Troubleshooting the GC
30 minutes Small group exercise #2 Troubleshooting the GC
15 minutes Questions and Discussion
30 minutes Written Assessment
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Course: Gas Chromatography What is Going on Inside the Box?
Name: ____________________________________________________________
Date: ____________________
Score: ___________________

Multiple choice. Select the correct answer from the choices given.

1. The __________ phase is a gas phase known as the carrier gas, which moves
through the system and carries the sample.
A. Stationary phase
B. Mobile phase
C. All of the above
D. None of the above

2. __________ injectors can be used to introduce a small amount of sample
into the system without being purged to waste during the injection.
A. Splitless
B. Split
C. All of the above
D. None of the above

3. The _________ phase is a column with a matrix or coating of particles that
the mobile phase passes through or across respectively.
A. Stationary phase
B. Mobile phase
C. All of the above
D. None of the above

4. ___________ remove volatile gasses from within a sample vial.
A. Headspace samplers
B. Flame ionization detectors
C. Capillary columns
D. Splitless injectors

5. __________ injectors vaporize the sample and vent the majority of the
sample to waste; only a small portion of sample enters the column.
A. Splitless
B. Split
C. All of the above
D. None of the above
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6. Which of the following statements is not true about Flame Ionization
Detectors?
A. The detector is a destructive detector, a detector that consumes the
sample.
B. The sample is ionized in a hydrogen flame that ignites and burns the
sample.
C. The detector contains both a reference channel and a sample channel.
D. All of the statements above are true.

7. Which type of peaks may result due to overloading the detector?
A. Flat top peaks
B. Split peaks
C. Both A and B
D. All of the above

8. What type of peak may result due to poor sample injection?
A. Flat top peaks
B. Split peaks
C. Both A and B
D. All of the above

9. What is typically the probably cause of ghost peaks?
A. Overloading the detector
B. Poor sample injection
C. Improper installation of column
D. Contamination
E. All of the above

10. By _______ the temperature and forcing a sample through a column, most
compounds can be separated efficiently.
A. decreasing
B. ramping
C. stabilizing
D. None of the above

Complete only if any questions are missed:
I have discussed the question(s) with the trainer, and I now understand the answer
to the missed question(s).

Signature and Date: ________________________________________________
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Formative Evaluation Questionnaire
Course: Gas Chromatography What is Going on Inside the Box?
The questions below evaluate instructional adequacy, which assesses how well the content provides
support for learning and meeting all instructional objectives. For each question, select the answer that
most closely identifies with your reaction to the printed PowerPoint slides. Please explain each question
answered No in the space provided under the questions. You may provide additional feedback and/or
suggestions on the printed PowerPoint slides.

Yes No N/A
Is the course content accurate?
If no, please note inaccuracies you find below:



Is the course content logical and well organized?
If no, please indicate what parts of the content require attention below:



Are the course objectives clearly defined?
If no, please explain which course objectives need to be refined for better
understanding:



Does the course content help achieve the objectives?
If no, please explain below what you think is missing or needs to be changed in
the content that does not allow you to achieve the objectives.


Are examples meaningful and helpful?
If no, please list which examples need work below:



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Are questions presented clearly?
If no, which questions are unclear?



Does answering the questions help achieve the objectives?
If no, which questions do not aid in achieving objectives?



Are important points emphasized?
If no, please explain which important points require more emphasis:



Is the quantity of information in the course comfortable?
If no, please explain if the quantity of information was too much, too little, too
easy, too hard, etc. Please be specific.



Are directions clear and easy to follow?
If no, please explain which set of directions are hard to understand.



Do the interactions in the class make learning easier?
If no, please explain how the interactions can aid in the students learning:




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Is the text clear and easy to read?
If no, please explain what makes the text difficult to read (font style, font size,
etc.):



Is the text clear and easy to understand?
If no, please explain where the text is hard to understand (you can list specific
PowerPoint slides, if desired:



Are the course contents attractive to look at?
If no, please note where you think the contents need more refinement to make it
more attractive:



Are there sufficient numbers of examples and practice items included in the
course?
If no, please give the parts of the content where more examples and practice
items are desired for further understanding:




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The questions below address cosmetic adequacy, which assesses how the course materials look. The
two areas evaluated are appearance and clarity. For each question, select the answer that most closely
identifies with your reaction. Please explain each question answered No in the space provided under
the questions.

Yes No N/A
Is it easy to understand the organization of each presentation slide?
If no, please explain where the presentation appears disorganized:



Are graphics adequate (not too simple, not too detailed)?
If no, please explain if graphics were too simple, too detailed, inappropriate, etc.



Is the text free of typographical errors?
If no, please give the location of typographical errors you have discovered:



Are colors and graphics attractive and not distracting?
If no, please specify the presentation slides that are unattractive or distracting
and why:



Do colors and graphics aid in learning?
If no, please specify the presentation slides that need work and why:


Are questions presented clearly?
If no, please explain which questions are unclear:



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Additional Comments and Suggestions:
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Summative Evaluation Questionnaire
Course: Gas Chromatography What is Going on Inside the Box?
The questions below evaluate the content, activities, and instructor. For each question, select the answer
that most closely identifies with your reaction. Please explain each question answered No in the space
provided under the questions.

Yes No N/A
The content covered was fitting for my job tasks.
If no, explain why this content is not necessary in your everyday tasks:


The content was logical and well organized.
If no, please explain where the content appeared disorganized and/or unclear:


The presentation slides were appropriate and beneficial to my learning.
If no, please explain which slides you thought were unnecessary to your
learning:


All small group exercises were appropriate and beneficial to my learning.
If no, please explain which group exercise(s) were not appropriate or
beneficial:


Instructor was knowledgeable.
If no, please explain what part(s) of the course did the instructor appear
inexperienced:


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The instructors presentation of the content was satisfactory.

If no, please list ways to improve the presentation of the content below:



Additional Comments and Suggestions:
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Summative Evaluation Questionnaire
Course: Gas Chromatography What is Going on Inside the Box?
For each question, select the answer that most closely identifies with your reaction. Please explain each
question answered No in the space provided under the questions.

Yes No N/A
Do you feel that you have expanded your knowledge of gas chromatography
by taking the course?
If no, please explain any discrepancies noted between the course and your
current practice running GC:


Do you routinely use the skills gained from taking the course?
If no, please indicate how often you use the skills gained from the course:


Since the class, have you run GC?

Since the class, do you feel more at ease running and troubleshooting the
GC?
If no, please indicate what makes you uneasy when running or
troubleshooting the GC:


Since the class, do you feel that you make less mistakes when running GC?
Do you feel like the quality of your GC analytical work has increased since
the class?


Additional Comments and Suggestions:
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