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Course Code: 
PHAR 548
Course Type: 
Area Elective
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Coordinator: 
Course Objectives: 
The aim of this course to teach the students accreditation concept, and whole process in a qualified laboratory.
Course Content: 

Accreditation processes, ISO 17025 quality system, GLP system, case study via frequently used analytical instruments, validation procedure, investigation of examples.

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 troth, E: Oral Exam F: Portfolio, G: Contrabution of course activities H:Homework

Vertical Tabs

Course Learning Outcomes

Learning Outcomes

Programme learning outcomes

Teaching Methods

Assessment Methods

1) Student knows accreditation concept

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

2) Student knows basic properties of ISO 17025 standard document

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

3) Staudent has information about GLP system

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

4)  Explains the necessity for the methods of analysis used in the validation process

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

5) Describes the validation parameters examined and tested techniques acquired

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

6) Gives up-to-date information about the application of analytical techniques

1,2,3,4,5,7,8,9,10

1,2,3,4

A,H,I

Course Flow

COURSE CONTENT

Week

Teorical Topics                                     

Study Materials

1

Introduction to Drug Analysis

Textbook, Lecture notes

2

Laboratory Accreditation

Textbook, Lecture notes

3

Standardization

Textbook, Lecture notes

4

Documentation

Textbook, Lecture notes

5

TS EN ISO/ IEC 17025 System

Textbook, Lecture notes

6

TS EN ISO/ IEC 17025 System

Textbook, Lecture notes

7

GLP System

Textbook, Lecture notes

8

Case study for basic methods

Textbook, Lecture notes

9

Case study for basic methods

Textbook, Lecture notes

10

Case study for spectrophotometry methods

Textbook, Lecture notes

11

Case study for cell studies

Textbook, Lecture notes

12

Case study for cell studies

Textbook, Lecture notes

13

Case study for HPLC

Textbook, Lecture notes

14

Case study for HPLC

Textbook, Lecture notes

 
 

Recommended Sources

Textbook

Lecture notes

Additional Resources

ISO 17025 dökümanı,

https://www.eptis.org/index.htm

https://www.turkak.org.tr/

https://www.ich.org/

https://www.iso.org/home.html

 

Material Sharing

Documents

Pdf form of the Lecture notes

Assignments

-

Exams

 
 
 

Assessment

ASSESSMENT

IN-TERM STUDIES

NUMBER

PERCENTAGE

Midterm  Exam

1

100

Quiz (Homework)

-

-

Laboratory

-

-

Laboratory Exam

-

-

Total

 

100

CONTRIBUTION OF FINAL EXAMINATION TO OVERALL GRADE

1

60

CONTRIBUTION OF IN-TERM STUDIES TO OVERALL GRADE

1

40

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.

 

 

X

 

 

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

32

Hours for off-the-classroom study (Pre-study, practice)

16

2

32

Midterm Exams

1

5

5

Lab. Applications

-

-

-

Hours for off-the-Lab. study (Pre-study, practice)

-

-

-

Lab. Midterm Exem

-

-

-

Lab. Final

-

-

-

Homework

-

-

-

Final

1

10

10

Total Work Load

 

 

79

Total Work Load / 25 (h)

 

 

3.16

ECTS Credit of the Course

 

 

3