CCOG for BIT 126 Fall 2022
- Course Number:
- BIT 126
- Course Title:
- Applied Quality Practice
- Credit Hours:
- Lecture Hours:
- Lecture/Lab Hours:
- Lab Hours:
Intended Outcomes for the course
- Follow established procedures in compliance with quality system requirements in a regulated bioscience environment.
- Perform basic quality functions according to standard operating procedures in a regulated bioscience environment.
- Record work functions using established documentation formats.
- Recognize and exhibit personal and professional behaviors, including efficient (LEAN) work habits that are appropriate in a regulated work environment.
- Communicate effectively to perform coordinated tasks as a member of a team.
Course Activities and Design
Students will apply FDA/ISO quality system concepts while working in teams to produce a bioscience product in the laboratory following accepted industry practices. Throughout the course, the students will explore themes, concepts and issues listed below.
Outcome Assessment Strategies
- Documentation, including but not limited to: Standard Operating Procedures, Batch Records, Forms. Frequent evaluation and feedback to
- Practical assessment of skill in conducting quality functions in compliance with established procedures, both individually and as a member of a team.
- Written exams and quizzes
Course Content (Themes, Concepts, Issues and Skills)
Themes: Topics that thread through all of the instruction
- Compliance with regulations
- Acceptance criteria
- Document control
- Records keeping
- Change control
Concepts: Things that need to be known and understood in support of the outcomes
- CAPA (Corrective Action Preventive Action)
- Audit (internal, customer, regulatory, supplier)
- Environmental Control
- Equipment Measurement and Calibration
- Accuracy and precision
- Acceptance Activities
- Material Control
- Design inputs and outputs
Issues: Things that may need to be “overcome” in order to achieve the outcomes
- Following detailed written instructions
- Time-management/Efficiency to eliminate waste of resources
- Proper communication channels
Skills: Mastered by repetition and practice in order to achieve the outcomes
- Using computers for obtaining information, using forms, record-keeping, communication
- Documentation in compliance with established regulatory procedure.
- Effective communication, both written and oral.
- Follow established written procedures to consistently carry out functions in a regulated work environment.
- Recognize non-conformities, perform root-cause analysis and apply CAPA.
- Coordinated teamwork