GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR

COURSE DESCRIPTION

QUALITY ASSURANCE AND VALIDATION/FTE-6070

Course Title:	QUALITY ASSURANCE AND VALIDATION
Credits	3	ECTS	8
Semester	1	Compulsory/Elective	Compulsory

COURSE INFO

-- LANGUAGE OF INSTRUCTION

Turkish

-- NAME OF LECTURER(S)

Prof. Füsun Acartürk, Prof. Sevgi Takka

-- WEB SITE(S) OF LECTURER(S)

http://www.websitem.gazi.edu.tr/site/acarturk, http://www.websitem.gazi.edu.tr/site/takka

-- EMAIL(S) OF LECTURER(S)

acarturk@gazi.edu.tr, sevgitakka@yahoo.com

-- LEARNING OUTCOMES OF THE COURSE UNIT

Learning the basic concepts and information related to quality assurance and validation
Quality assurance, safety, efficiency, validation types (retroscopic, prospective, revalidation, concurrent)
Validation in different drug forms
Quality control and quality assurance

-- MODE OF DELIVERY

The mode of delivery of this course is face to face

-- PREREQUISITES AND CO-REQUISITES

There is no prerequisite or co-requisite for this course

-- RECOMMENDED OPTIONAL PROGRAMME COMPONENTS

There is no recommended optional programme component for this course.

--COURSE CONTENT
1. Week	Quality assurance and organization
2. Week	Quality assurance and pharmaceutical development
3. Week	Quality assurance and manufacturing
4. Week	Regulatory affairs for process validation (ICH Q8 guideline)
5. Week	ICH Q9 ve ICH Q10 guidelines
6. Week	Prospective process validation
7. Week	Retrospective validation
8. Week	Revalidation, concurrent validation
9. Week	Active substance validation
10. Week	Validation of solid dosage forms
11. Week	Validation of liquid and semi-solid dosage forms
12. Week	Validation of sterilization
13. Week	Validation of lyophilazation
14. Week	Cleaning validation
15. Week
16. Week

-- RECOMMENDED OR REQUIRED READING

- Good Manufacturing Practices for Pharmaceuticals. S.H.Willing, Marcel Dekker, NewYork, 2001 - Pharmaceutical Process Validation, R.A.Nash, A.H.Wachter, Marcel Dekker, NewYork, 2003

-- PLANNED LEARNING ACTIVITIES AND TEACHING METHODS

Lecture, Question & Answer

-- WORK PLACEMENT(S)

-- ASSESSMENT METHODS AND CRITERIA

	Quantity	Percentage
Mid-terms	1	5
Assignment	1	10
Exercises	0	0
Projects	1	25
Practice	0	0
Quiz	0	0
Contribution of In-term Studies to Overall Grade		40
Contribution of Final Examination to Overall Grade		60

-- WORKLOAD

Efficiency	Total Week Count	Weekly Duration (in hour)	Total Workload in Semester
Theoretical Study Hours of Course Per Week	14	3	42
Practising Hours of Course Per Week	0	0	0
Reading	9	5	45
Searching in Internet and Library	10	6	60
Designing and Applying Materials	0	0	0
Preparing Reports	3	6	18
Preparing Presentation	3	5	15
Presentation	1	3	3
Mid-Term and Studying for Mid-Term	1	7	7
Final and Studying for Final	1	10	10
Other	0	0	0
TOTAL WORKLOAD:			200
TOTAL WORKLOAD / 25:			8
ECTS:			8

-- COURSE'S CONTRIBUTION TO PROGRAM

NO	PROGRAM LEARNING OUTCOMES	1	2	3	4	5
1						X
2						X
3						X
4						X
5						X
6					X
7					X
8					X
9						X
10						X

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GAZI UNIVERSITY INFORMATION PACKAGE - 2019 ACADEMIC YEAR