BTEC 12B - GMP Compliance - Stage 4 - Kaeuper
Assessment
| Assessment Methods | Student satisfaction surveys |
|---|---|
| Assessment Description | Students responded to questions assessing how well they think they learned the material related to 7 key Student Learning Outcomes, as well as rating their overall learning experience in this course. Example questions include: “Explain why batch records are kept and monitored closely?” and “Name two purposes of an FDA form 483 following an FDA inspection?”. The possible self-assessment scores ranged from 1 (low level of learning) to 10 (high level of learning). For analysis and improvement planning, an average score was calculated for each question. |
| Learning Outcomes | A. Explain the FDA regulations for product labeling? B. List the major stages of validation and identify common validation documents? C. Explain why batch records are kept and monitored closely? D. Evaluate cleaning scenarios and determine if the equipment is clean? E. Explain why raw materials are quarantined? F. Define the importance of process control? G. Name two purposes of an FDA form 483 following an FDA inspection? |
| Number of Sections | 1 |
| Number of Instructors | 1 |
| Number of Students | 28 |
Data Analysis
| Data Shared With | Instructors of the same course (at CCSF) |
|---|---|
| Data Sharing Methods | Face-to-face meetings |
| Data Summary | Of the 7 key Student Learning Outcomes assessed, four outcomes received a 9/10 score for level of learning, and the remaining three outcomes received a 10/10 score for level of learning. The overall average score for student learning experience in this course was 9/10. |
| Analysis Summary | Criteria: Self-assessment average scores greater than or equal to 7/10 indicates outcome achievement. For the 7 key Student Learning Outcomes assessed, all outcomes were achieved. Additionally, a high level of overall learning experience (9/10) was achieved. |
| Next Steps Planned | For the Fall 2013 course, updates will be made to the quizzes, activities and lectures. Greater emphasis will be placed on the two Student Learning Outcomes which received the lowest average scores – validation and process control concepts. |
| Learning Outcomes | List the major stages of validation and identify common validation documents, and Define the importance of process control. |
Changes
| Details | This semester included more (graded) homework assignments so students could tell how they were doing prior to the midterm. To determine the final grade for the course, the weighting of “Participation, quizzes and homework” was increased to 30%. A document completion and audit activity on Quality Control and Quality Assurance was added. Lectures were updated to detail the major sources of error in manufacturing, describe how SOPs and Batch Records relate to each other, and emphasize the goal of quarantine. |
|---|---|
| Learning Outcomes | ALL. |
Tentative Future Plans
| Term | Spring 2014 |
|---|---|
| Activities |
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| More Details | N/A |
SLO Details Storage Location
HARD COPY - In a department filing system (department office)