| Week |
Subject |
Related Preparation |
| 1) |
The importance and purpose of quality control in the pharmaceutical industry |
Textbook |
| 2) |
Introduction to fundamental concepts such as GMP, GLP, QbD, QbT, PAT |
Textbook |
| 3) |
Chemical controls: chemical analysis techniques and methods |
Textbook |
| 4) |
Chemical controls: Chemical analysis of pharmaceutical raw materials and products |
Textbook |
| 5) |
Principles and implementation of biological tests |
Textbook |
| 6) |
Conducting microbiological tests and interpreting the results |
Textbook |
| 7) |
Quality Assurance and Risk Management |
Textbook |
| 8) |
Midterm Exam 1 / Topic Review |
|
| 9) |
Validity of analytical methods and parameters |
Textbook |
| 10) |
Evaluation of quality control data, reporting of results, and interpretation |
Textbook |
| 11) |
ICH guidelines and international regulations |
Textbook |
| 12) |
Good Manufacturing Practices (GMP) |
Textbook |
| 13) |
ISO 9001 and other quality standards |
Textbook |
| 14) |
Application of (PAC) and (PAT) in pharmaceutical manufacturing processes |
Textbook |
| 15) |
Final |
|
| Course Notes / Textbooks: |
Handbook of Modern Pharmaceutical Analysis, Satinder, Ahuja,Stephen Scypinski, 2001 Pharmaceutical Analysis, David G. Watson,2012 Pharmaceutical Analysis, David C Lee, Michael. Webb,2009 |
| References: |
Handbook of Modern Pharmaceutical Analysis, Satinder, Ahuja,Stephen Scypinski, 2001 Pharmaceutical Analysis, David G. Watson,2012 Pharmaceutical Analysis, David C Lee, Michael. Webb,2009 |
| |
Program Outcomes |
Level of Contribution |
| 1) |
To be able to use advanced theoretical and practical knowledge acquired in the field |
1 |
| 2) |
To be able to interpret and evaluate data using advanced knowledge and skills acquired in the field, to be able to identify and analyze problems, to be able to develop solutions based on research and evidence. |
1 |
| 3) |
To be able to plan and manage activities for the development of employees under his/her responsibility within the framework of a project. |
1 |
| 4) |
To act in accordance with social, scientific, cultural and ethical values in the stages of collecting, interpreting, applying and announcing the results of data related to the field. |
1 |
| 5) |
To be able to carry out an advanced level study related to the field independently. |
1 |
| 6) |
To be able to take responsibility individually and as a team member to solve complex and unforeseen problems encountered in applications related to the field. |
2 |
| 7) |
To have advanced theoretical and practical knowledge supported by textbooks, application tools and other resources containing up-to-date information in the field. |
2 |
| 8) |
To have sufficient awareness of the universality of social rights, social justice, quality culture and protection of cultural values, environmental protection, occupational health and safety. |
2 |
| 9) |
To be able to inform the relevant people and institutions about the issues related to the field; to be able to convey his / her thoughts and suggestions for solutions to problems in written and orally. |
2 |
| 10) |
To be able to share his/her thoughts and suggestions for solutions to problems related to his/her field with experts and non-experts by supporting them with quantitative and qualitative data. |
2 |
| 11) |
To be able to organize and implement projects and activities for the social environment in which he/she lives with a sense of social responsibility |
1 |
| 12) |
To be able to evaluate the advanced knowledge and skills acquired in the field with a critical approach |
2 |
| 13) |
To be able to identify their learning needs and direct their learning |
1 |
Istanbul Health and Technology University INFORMATION PACKAGE / COURSE CATALOGUE