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Course Code: 
PHAR 553
Course Type: 
Elective
P: 
2
Lab: 
0
Credits: 
2
ECTS: 
3
Course Language: 
English
Course Coordinator: 
Ebru TÜRKÖZ ACAR
Courses given by: 
Ebru TÜRKÖZ ACAR
Course Objectives: 
The aim of this course to teach the students validation procedures for pharmaceutical analysis.
Course Content: 

Qualification systems, validation process, validation parameters, EMEA, FDA, USP, ICH  validation guidelines, investigation of application of these guidelines to some samples in literature, controlling of the processes according to the validation guidelines.

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 validation procedure

1,2,3,5,8,10

1,2,3,4

A,H,I

2) Student knows basic of validation procedure

1,2,3,5,8,10

1,2,3,4

A,H,I

3) Student knows validation parameters

1,2,3,5,8,10

1,2,3,4

A,H,I

4) Students can evaluate an analysis procedure according to a validation guideline

1,2,3,5,8,10

1,2,3,4

A,H,I

5) Students can comment neccesities of the validation procedure according to a validation guideline

1,2,3,5,8,10

1,2,3,4

A,H,I

Course Flow

COURSE CONTENT

Week

Theoretical Topics                                     

Study Materials

1

Introduction to Qualified Systems

Textbook, Lecture notes

2

Why is validation process needed for a qualified laboratory?

Textbook, Lecture notes

3

Evaluation of FDA Validation Guideline

Textbook, Lecture notes

4

Evaluation of USP Validation Guideline

Textbook, Lecture notes

5

Evaluation of EMEA Validation Guideline

Textbook, Lecture notes

6

Evaluation of FDA Validation Guideline

Textbook, Lecture notes

7

Validation Plan for Spectroscopy Methods

Textbook, Lecture notes

8

Validation Plan for Spectroscopy Methods

Textbook, Lecture notes

9

Validation Plan for Electrochemical Methods

Textbook, Lecture notes

10

Validation Plan for Electrochemical Methods

Textbook, Lecture notes

11

Validation Plan for Chromatography Methods

Textbook, Lecture notes

12

Validation Plan for Chromatography Methods

Textbook, Lecture notes

13

Presentations by students

-

14

Presentations by students

-
 

Recommended Sources

RECOMMENDED SOURCES

Textbook

Lecture notes

Additional Resources

Validation guidelines obtained from USP, EMEA, ICH, FDA websites.
 
 

Material Sharing

MATERIAL SHARING

Documents

PDF form of the Lecture notes
 

Assessment

ASSESSMENT

IN-TERM STUDIES

NUMBER

PERCENTAGE

Midterm  Exam

1

50

Contribution of Final Examination to Overall Grade

1

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.

 

 

 

 

 

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.

 

 

 

 

 

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

1

3

Lab. Applications

-

-

-

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

-

-

-

Lab. Midterm Exem

-

-

-

Lab. Final

-

-

-

Homework

-

-

-

Final

1

10

10

Total Work Load

 

 

77

Total Work Load / 25 (h)

 

 

3.08

ECTS Credit of the Course

 

 

3
 
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