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Course Code: 
PHAR 553
Course Type: 
Elective
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Coordinator: 
Courses given by: 
Course Objectives: 
To teach students about laboratory quality management systems and validation process of different type of analytical methods.
Course Content: 

This course include some information on importance of quality management systems for test/analysis laboratories, why is needed to validation of analytical methods, validation processess of analytical methods and some applications of these processess.

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) The student knows the importance of quality management systems for test/analysis laboratories

4, 5, 6, 8, 10, 14

1,2,3,4,5,6

A, H

2) The student knows used quality management systems in test-analysis laboratories.

4, 5, 6, 8, 10, 14

1,2,3,4

A, H

3) The student knows that different analytical methods have different validation approach.

4, 5, 6, 8, 10, 14

1,2,3,4,6,7

A, H

4) The student has knowledge on validation processess.

4, 5, 6, 8, 10, 14

1,2,3,4

A,H

5)  The student has knowledge on evaluation of validation processess.

4, 5, 6, 8, 10, 14

1,2,3,4

A,H

Course Flow

Week

Teorical Topics                                     

Study Materials

1

Test- Analysis Laboratories and functions

Lecture notes, internet

2

Test- Analysis Laboratories and Quality Management System

Lecture notes, internet

3

Quality Management Systems

Lecture notes, internet

4

Validation processess

Lecture notes, internet

5

Validation processess

Lecture notes, internet

6

Validation of classical analytical methods

Lecture notes, internet

7

Literature work

Lecture notes, internet

8

Validation of atomic spectroscopy method

Lecture notes, internet

9

Literature work

Lecture notes, internet

10

Validation of UV-Vis Spectroscopy Method

Lecture notes, internet

11

Literature work

Lecture notes, internet

12

Validation of chromatography methods

Lecture notes, internet

13

Literature work – Gas Chromatography

Lecture notes, internet

14

Literature work – Liquid Chromatography

Lecture notes, internet

 

Recommended Sources

Textbook

1-Lecture Notes

2- Skoog &West, Analytical Chemistry

3- Harris, Quantitative Analytical Chemistry

Additional Resources

Internet (google scholar, Pubmed, web of Science)

 

Material Sharing

Documents

Documents will be shared on Google clasroom or moodle

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’s Contribution to Program

COURSE'S CONTRIBUTION TO PROGRAM

No

Program Learning Outcomes

Contribution

1

2

3

4

5

1

Acquire skills needed to practice the profession of pharmacy in either a Turkish or an English language setting.

         

2

Being equipped to access current theoretical and applied knowledge, keeping abreast of new developments, and possessing the critical faculties enabling an accurate and reliable interpretation and assessment of this information.

     

X

 

3

Having the capacity to apply the skills acquired in the field of pharmaceutical science. Possessing the ability to harness his/her acquired knowledge in order to function as a highly accessible health counsellor, providing a ready source of clinically relevant, health-related information to the general public.

         

4

Keeping abreast of and being equipped to apply the fundamental pharmaceutical and health science principles which guide future developments in modern technology, and being able to share these experiences and skills with colleagues through participatation in professional development education seminars.

       

X

5

Knowing how to assess risks arising from the use of drugs and other chemicals and those risks potentially encounterd during laboratory practice.

       

X

6

Acquiring the skills and knowledge needed to interpret findings obtained through quantative and qualitative measurements, and thus reach valid, scientific conclusions based on this data. 

       

X

7

Being able to compound pharmaceutical products while being knowledgable about their clinical application, interactions, side effects and risks  and apply in proper manner .

         

8

Being competent to conduct and manage research and development projects, and share experimental outcomes.

       

X

9

Be competent to accurately and intelligibly communicate clincally relevant information to patients concerning prescription items and other pharmaceutical products.  

         

10

Being able to function in a multidisciplinary environment. Possessing the skill to collaborate and establish lines of communication with other professionals, while developing their own professional competency through participation in relevant continuing education activities.

       

X

11

Being able to play a role in projects which fulfills the profession’s societal responsibilities. Participating in professional activities and undertaking duties in a manner which reflects an awareness of and sensitivity to environmental issues.

         

12

Being capable of opening a community pharmacy, practicing in a hospital pharmacy setting, and offering service in any field related to drugs, cosmetics, medical  and/or plant-derived products. Able to play an active role in his/her own personal professional development, as well as that of colleagues and pharmaceutical students.

         

13

Able to play a role in issues related to public health as a member of the health care team while being cognizant of and able to fulfill legal and professional requirements and maintain ethical standards. 

         

14

Is knowledgable of and equipped to manage the planning, development, compounding and quality control analysis of naturally occuring and synthetic medicines, while also being aware of the processes related to these products’ absorption, distribution, metabolism and excretion from the body.

       

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

1

16

Midterm Exams

1

10

10

Lab. Applications

-

-

-

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

-

-

-

Lab. Midterm Exem

-

-

-

Lab. Final

-

-

-

Homework

-

-

-

Final

1

15

15

Total Work Load

 

 

73

Total Work Load / 25 (h)

 

 

2.92

ECTS Credit of the Course

 

 

3