Data
Official data in SubjectManager for the following academic year: 2024-2025
Course director
Pongrácz Judit Erzsébet
professor,
Department of Pharmaceutical Biotechnology
Number of hours/semester
Lectures: 14 hours
Practices: 0 hours
Seminars: 14 hours
Total of: 28 hours
Subject data
- Code of subject: OBH-016-T
- 2 Credit
- Biotechnology MSc
- Specialty in Medical Biotechnology module
- autumn
haven't
Course headcount limitations
min. 1 people – max. 50 people
Topic
Biotechnology quality assurance is an important issue in industrial and laboratory setting. The topics will aid the students to think accordingly.
Lectures
- 1. Quality of production efforts I. - Bóvári-Biri Judit
- 2. Quality of production efforts II. - Bóvári-Biri Judit
- 3. Quality assurance products I. - Bóvári-Biri Judit
- 4. Quality assurance products II. - Bóvári-Biri Judit
- 5. International standards I. - Bóvári-Biri Judit
- 6. International standards II. - Bóvári-Biri Judit
- 7. Company quality I. - Bóvári-Biri Judit
- 8. Company quality II. - Bóvári-Biri Judit
- 9. Quality assurance in practice I. - Bóvári-Biri Judit
- 10. Quality assurance in practice II. - Bóvári-Biri Judit
- 11. Quality control I. - Bóvári-Biri Judit
- 12. Quality assurance in practice II. - Bóvári-Biri Judit
- 13. Quality assurance in the medical industry I. - Bóvári-Biri Judit
- 14. Quality assurance in the medical industry II. - Bóvári-Biri Judit
Practices
Seminars
- 1. Best practice - Bóvári-Biri Judit
- 2. Data quality - Bóvári-Biri Judit
- 3. Data integrity - Papp Alexandra
- 4. The 150 system - Papp Alexandra
- 5. Software testing - Papp Alexandra
- 6. Software testing quality assurance - why is it important in medical system - Papp Alexandra
- 7. Quality infrastructures management - Papp Alexandra
- 8. Consulatance in quality assurance - Papp Alexandra
- 9. Verification and validation - Papp Alexandra
- 10. Project presentation I. - Papp Alexandra
- 11. Project presentation II. - Papp Alexandra
- 12. Summary I. - Papp Alexandra
- 13. Summary II. - Papp Alexandra
- 14. Test - Papp Alexandra
Reading material
Obligatory literature
Literature developed by the Department
lecture and seminar ppt
Notes
Recommended literature
Keen&Pongracz: Medical biotechnology, Elsevier - Departmental website
K.E. Avis, C.M. Wagner, V.L. Wu: Biotechnology Quality Assurance and Validation - CRC Press
Conditions for acceptance of the semester
Participation on 75% of lectures and site visits
Mid-term exams
Written test
Making up for missed classes
None
Exam topics/questions
Departmental website, Medical biotechnology
Examiners
Instructor / tutor of practices and seminars
- Bóvári-Biri Judit
- Papp Alexandra