Course Objectives
To acquire the essential skills to conduct stability studies on pharmaceutical products and manage the stability chambers systems following the best practices with good documentation of the stability files according to Egyptian MOH requirements.
Detailed Intended Learning Objectives (ILOs):
This course is designed to make the participants acquire a clear-cut understanding of:
- Mention the stability study requirements for different dosage forms.
- Prepare the stability study files according to Egyptian MOH requirements.
- Communicate efficiently with the mentality of the auditors from different bodies regarding to the stability department.
- Deal professionally with different cases of stability chambers problems (NOT including engineering solutions).
- Understand basic concepts and requirements of ICH guidance relevant to stability studies.
Course Content
2 Days Course
Day 1:
- Introduction to stability guidelines.
- Purposes of stability studies.
- Types of stability studies.
- Climatic zones (Egypt and export).
- Tests and acceptance criteria.
Day 2:
- Stability sample requirements and handling of samples.
- Statistical study.
- Stability file preparation.
- Exam.
Consultant
Dr. Mohammed Amin
- More Than 13 years of experience in the Pharmaceutical Industry
- Stability studies consultant at Stability centers
Price Options
70% Special Discount
Clients From outside Egypt:
90 USD
(Instead of 300 USD)
Clients From Inside Egypt:
700 L.E
(Instead of 2335 L.E.)