Quality concept, development of quality concept, Total quality management, quality management systems at drug processes, related standard documents.
Vertical Tabs
Course Learning Outcomes
Learning Outcomes |
Programme learning outcomes |
Teaching Methods |
Assessment Methods |
1) Student knows basic information on quality concept |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,E,H,I |
2) Student knows information and development of quality processess. |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,H |
3) Student knows total quality management system |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,H |
4) Student knows that why quality processess are important for drug industry |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,H |
5) Student has knowledge on ICH Q10, ICH Q7 and PICS systems |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,H |
6) Student knows importance of data integrity concept for drug processess |
1,2,3,4,5,7,10 |
1,2,3,4,6 |
A,B,C,D,H |
Course Flow
COURSE CONTENT |
||
Week |
Teorical Topics |
Study Materials |
1 |
Introduction to quality |
Lecture notes and other documents |
2 |
History of Quality |
Lecture notes and other documents |
3 |
Quality Management Systems (ICH, Eudralex, ISO) |
Lecture notes and other documents |
4 |
Total Quality Management |
Lecture notes and other documents |
5 |
Quality Management in Pharmacy (Cases) |
- |
6 |
Quality Management in Pharmacy (Basic Concepts) |
Lecture notes and other documents |
7 |
Quality Management System (ICH Q10) |
Lecture notes and other documents |
8 |
Manufacturing of API & Intermadiates (ICH Q7 and PIC/S(Part II) |
Lecture notes and other documents |
9 |
Change Management |
Lecture notes and other documents |
10 |
Annual Product Quality Review |
Lecture notes and other documents |
11 |
GMP Fresher |
Lecture notes and other documents |
12 |
GMP Fresher |
Lecture notes and other documents |
13 |
Risk Management in Quality |
Lecture notes and other documents |
14 |
Quality Culture and Data Integrity |
Lecture notes and other documents |
Recommended Sources
Textbook |
Lecture notes |
Additional Resources |
http:// ec.europa.eu/health/documents/eudralex/ http://www.iegm.gov.tr/Default.aspx?sayfa=kalite_sbmev&lang=tr-tr&thelaw... |
Material Sharing
Documents |
Lecture notes, ICH guideline, PICS guideline |
Assignments |
1 homework |
Exams |
1 Midterm, 1 Final |
Assessment
IN-TERM STUDIES |
NUMBER |
PERCENTAGE |
Midterm Exam I |
1 |
50 |
Assignment-homework |
1 |
50 |
|
||
Total |
|
100 |
CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE |
|
50 |
CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE |
|
50 |
Total |
|
100 |
COURSE CATEGORY |
Compulsary/Elective |
Course’s Contribution to Program
COURSE'S CONTRIBUTION TO PROGRAM |
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No |
Program Learning Outcomes |
Contribution |
||||
1 |
2 |
3 |
4 |
5 |
||
1 |
Has national and international up-to-date, theoretical and applied knowledge in the field of pharmacy. |
|
X |
|
|
|
2 |
Defines problems related to the profession, collects data, evaluates its accuracy and reliability, develops evidence-based solutions, shares them with healthcare professionals, makes necessary explanations to other people. |
|
|
|
X |
|
3 |
Communicates accurately and effectively in accordance with cultural and ethical values with all relevant professional groups, especially those working in the field of health, and all segments of society, using information and communication technologies. |
|
|
|
|
X |
4 |
Takes into account the law and ethics when dealing with public health issues. |
|
|
|
|
|
5 |
Acts as a pharmacist with high career awareness, self-confidence, leadership spirit, who is prone to teamwork, entrepreneurial, productive and able to manage financial resources. |
|
|
|
X |
|
6 |
Based on the principle of pharmaceutical care, Acts as an easily accessible health consultant with a patient-oriented approach and plays an active role in constantly informing the society. |
|
|
|
|
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7 |
Improves his/her knowledge by participating in in-service training and activities in line with the needs of the century and society, takes part in the professional development of colleagues and adopts the lifelong learning principle. |
|
|
X |
|
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8 |
Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results. |
|
|
X |
|
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9 |
Applies knowledge and skills for the benefits of the society taking part in social responsibility projects. |
|
X |
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10 |
Fulfills the requirements of quality management systems using the theoretical and applied knowledge acquired in the field. |
|
|
|
|
X |
ECTS
ECTS ALLOCATED BASED ON STUDENT WORKLOAD BY THE COURSE DESCRIPTION |
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Activities |
Quantity |
Duration |
Total |
Course Duration (Including the exam week: 16x Total course hours) |
16 |
2 |
31 |
Hours for off-the-classroom study (Pre-study, practice) |
16 |
2,5 |
40 |
Midterm Exams |
1 |
1 |
1 |
Lab. Applications |
- |
- |
- |
Hours for off-the-Lab. study (Pre-study, practice) |
- |
- |
- |
Lab. Midterm Exam |
- |
- |
- |
Lab. Final |
- |
- |
- |
Homework |
1 |
5 |
5 |
Final |
1 |
2 |
2 |
Total Work Load |
|
|
79 |
Total Work Load / 25 (h) |
|
|
3,16 |
ECTS Credit of the Course |
|
|
3 |