Course Information
Course Semester Plan
Course Information
|
No |
Module Name |
Validation of Analytical Methods |
|
1 |
Code of Subjects |
P10A02.0506 |
|
2 |
Study load |
2(2-0) credits Contact hour per semester: 27 Independent study hour per semester : 64 Total workload : 91 |
|
3 |
Semester |
5 |
|
4 |
Precondition |
P10A.0306 |
|
5 |
Competence |
After attending this lecture, students are able to explain and design validation methods in the development of reliable modern analytical methods, and analyze the validation parameters that are set in accordance with the requirements of ICH, USP and guidelines for industry |
|
6 |
Elements of Competency |
MKK |
|
7 |
Type Competency |
Main competence |
|
8 |
Syllabus |
In this course, participants will learn about the basis for validation of sample analysis methods in the pharmaceutical field, the characteristics of the validation and the type of analysis procedure; aspects in the development of analytical methods which include the importance of measuring error, standardization of analytical methods (external standards, internal standards, standard additions), optimization of analytical methods, validation of analytical methods, estimation of measurement uncertainty, qualification and verification, Factors that affect the accuracy of analysis results: processing experimental data with correct statistics, standard materials (reference), the influence of analysis conditions, and sampling, as well as validation protocols. |
|
9 |
Attribute Soft Skill |
Ethics, awareness, discipline |
|
10 |
Learning methods |
Presentation, lecturer, discussion, project |
|
11 |
Learning Media |
LCD Projector |
|
12 |
Appraisal |
Self-reflection : 20% Assignment : 20% Mid-Exam : 30% Final-Exam : 30% |
|
13 |
Lecturer |
Dr. Ida Musfiroh, Dr. Aliya Nur Hasanah, Dr. Rimadani Pratiwi, and Mutakin Ph.D |
|
14 |
References |
|
Course Semester Plan