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Course Code: 
PHAR 429
Course Period: 
Autumn
Course Type: 
Core
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Coordinator: 
Courses given by: 
Course Objectives: 
This course aims to teach the students basic concenpts of quality management systems like Quality assurance of drugs and GMP
Course Content: 

Quality concept, development of quality concept, Total quality management, quality management systems at drug processes, related standard documents.

Course Methodology: 
1: Lecture, 2: Question-Answer, 3: Discussion, 4: Presentation, 5:Simulation, 6: Video, 7: Applications, 8:Case Study
Course Evaluation Methods: 
A:Written exam, B: multiple chose , C:Filing the blank D:False and true, E: Oral Exam F: Portfolio, G: Contribution of course activities H:Homework I: Take-home exam

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://www.ich.org/

  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

 

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.

 

 

 

 

 

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

 

 

8

Suggests and manages multidisciplinary / interdisciplinary research and development projects related to pharmaceuticals, cosmetics, medical devices and shares their results.

 

 

X

 

 

9

Applies knowledge and skills for the benefits of the society taking part in social responsibility projects.

 

X

 

 

 

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

Activities

Quantity

Duration
(Hour)

Total
Workload
(Hour)

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