Main page
Education

Biotechnology Quality Assurance

Data

Official data in SubjectManager for the following academic year: 2024-2025

Course director

Number of hours/semester

lectures: 14 hours

practices: 0 hours

seminars: 14 hours

total of: 28 hours

Subject data

  • Code of subject: OBI-016-T
  • 2 kredit
  • Biotechnology MSc
  • Specialty in Pharmaceutical 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. - 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
Rólunk