- Course Number:
- BIT 126
- Course Title:
- Applied Quality Practice
- Credit Hours:
- Lecture Hours:
- Lecture/Lab Hours:
- Lab Hours:
- Special Fee:
Course DescriptionIntroduces concepts and skills that are needed by entry level workers in the regulated bioscience and related work environments. Emphasize validation, compliance, CAPA, audit, LEAN work habits, material and product control and coordinated quality teamwork through laboratory-based activities. Prerequisites: BIT 125 and BIT 109 or instructor permission.
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