Stability studies in pharmaceuticals

Online Course

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.

Before You Register

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Stability Studies Integramedix Free Webinar by Dr.Mohamed Amin

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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.

Course curriculum

1. Chapter 1 lesson 1 Introduction, Definition & Goals
2. Chapter 1 lesson 2 ICH Guidelines, Climatic Zones
3. Chapter 1 lesson 3 Semipermiable Container Dosage Form
4. Chapter 1 lesson 4 Testing Frequency
5. Chapter 1 lesson 5 Photostability Studies
6. Chapter 1 lesson 6 Regrigeration, freeze studies
7. Chapter 1 lesson 7 Other Types Of Stability Studies
8. Stability Management
1. Chapter 2 lesson 1 Sampling Design
2. Chapter 2 lesson 2 Bracketing Design
3. Chapter 2 lesson 3 Important Notes
4. Chapter 2 lesson 4 Matrixing
5. Chapter 2 lesson 5 Handling and Analysis of Samples
6. Chapter 2 lesson 6 Chemical and Physical Properties
7. Chapter 2 lesson 7 Added substances, Analytical Methods
1. Chapter 3 lesson 1 stability chambers
2. Chapter 3 lesson 2 Tests under stability study
3. Chapter 3 lesson 3 Acceotance criteria
4. Chapter 3 lesson 4 Labeling, Potential Instability issues of FPPs
5. Chapter 3 lesson 5 Evaluation
6. Chapter 3 Lesson 6 Last Section

About this course

Free
21 lessons
5 hours of video content

Instructor(s)

Instructor Dr. Mohammed Amin

+13 years of experience in the pharmaceutical industry Stability studies consultant at stability centers

FAQ

Who are the Target Audiences?

Personnel from the following departments: Fresh graduates. New employee in quality control, R&D (METHODOLOGY) and stability.
What is the training package?

Soft copy of the secured presentation. Printed Outline (For On-site attendance only).
What are the Prerequisites (From the trainee)?

To have previous experience in Pharmaceutical industry and/ or stability section (NLT 1 year). Previous knowledge of ICH stability guidelines "preferred".
Is there a Certificate at the end of the Course?

Yes Sure, INTEGRAMEDIX Ltd. provides the certificate after passing the exam. (In case of failure, a certificate of attendance will be provided.) Presented as PDF For online Attendees unless printed Format is requested. Presented in printed Format for On-site Attendees.