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Education

Biotechnology Quality Assurance

Data

Official data in SubjectManager for the following academic year: 2023-2024

Course director

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
Prerequisites:

-

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
Rólunk