Data
Official data in SubjectManager for the following academic year: 2023-2024
Course director
-
Dr. Judit Erzsébet PONGRÁCZ
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 kredit
- Biotechnology MSc
- Specialty in Medical Biotechnology modul
- autumn
-
Course headcount limitations
min. 1 – max. 50
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. - Dr. Pongrácz Judit Erzsébet
- 2. Quality of production efforts II. - Dr. Pongrácz Judit Erzsébet
- 3. Quality assurance products I. - Dr. Pongrácz Judit Erzsébet
- 4. Quality assurance products II. - Dr. Pongrácz Judit Erzsébet
- 5. International standards I. - Dr. Pongrácz Judit Erzsébet
- 6. International standards II. - Dr. Pongrácz Judit Erzsébet
- 7. Company quality I. - Dr. Pongrácz Judit Erzsébet
- 8. Company quality II. - Dr. Pongrácz Judit Erzsébet
- 9. Quality assurance in practice I. - Dr. Pongrácz Judit Erzsébet
- 10. Quality assurance in practice II. - Dr. Pongrácz Judit Erzsébet
- 11. Quality control I. - Dr. Pongrácz Judit Erzsébet
- 12. Quality assurance in practice II. - Dr. Pongrácz Judit Erzsébet
- 13. Quality assurance in the medical industry I. - Dr. Pongrácz Judit Erzsébet
- 14. Quality assurance in the medical industry II. - Dr. Pongrácz Judit Erzsébet
Practices
Seminars
- 1. Best practice
- 2. Data quality
- 3. Data integrity
- 4. The 150 system
- 5. Software testing
- 6. Software testing quality assurance - why is it important in medical system
- 7. Quality infrastructures management
- 8. Consulatance in quality assurance
- 9. Verification and validation
- 10. Project presentation I.
- 11. Project presentation II.
- 12. Summary I.
- 13. Summary II.
- 14. Test
Reading material
Obligatory literature
Literature developed by the Department
lecture and seminar ppt
Notes
Recommended literature
Medical biotechnology, Elsevier - Departmental website
Conditions for acceptance of the semester
Maximum of 25 % absence allowed
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
- Dr. Pongrácz Judit Erzsébet