Charisma

#	Content
1	Module 1: Introduction to Stability Programs
2	Module 2: Regulatory Requirements
3	Module 3: Types of Stability Studies
4	Module 4: Stability Study Design
5	Module 5: Stability Storage Conditions
6	Module 6: Stability Sample Management
7	Module 7: Stability Testing
8	Module 8: Stability Data Evaluation
9	Module 9: Investigation of Stability Results
10	Module 10: Stability Documentation
11	Module 11: Stability Chamber Management
12	Module 12: Regulatory Inspections
13	Module 13: Practical Workshops and Case Studies

#	Outcomes
	• Explain the purpose and regulatory requirements of stability programs.
	• Develop stability protocols aligned with ICH guidelines.
	• Classify different types of stability studies and their applications.
	• Manage stability chambers and environmental monitoring systems.
	• Schedule stability testing according to regulatory expectations.
	• Analyze stability data using appropriate statistical and trending techniques.
	• Determine product shelf life and storage conditions.
	• Identify and investigate stability failures, OOT, and OOS results.
	• Maintain complete and compliant stability documentation.
	• Prepare laboratories for regulatory inspections related to stability studies.

#	Participants
1	� • Quality Control (QC) Analysts
2	� • Quality Assurance (QA) Personnel
3	� • Stability Study Coordinators
4	� • Laboratory Supervisors
5	� • Laboratory Managers
6	� • Analytical Chemists
7	� • Microbiology Analysts
8	� • Validation Specialists
9	� • Pharmaceutical Manufacturing Personnel
10	� • Research and Development (R&D) Scientists
11	� • Regulatory Affairs Professionals
12	� • GMP Auditors
13	� • Product Development Scientists
14	� • Laboratory Technicians
15	� • Anyone involved in pharmaceutical stability testing and quality management