Charisma

#	Content
1	Module 1: Introduction to SUPAC
2	Module 2: Regulatory Framework and Guidelines
3	Module 3: Types of Post-Approval Changes
4	Module 4: Scale-Up Principles
5	Module 5: SUPAC-IR Requirements
6	Module 6: SUPAC-MR Requirements
7	Module 7: SUPAC-SS Requirements
8	Module 8: Regulatory Reporting Categories
9	Module 9: Stability and Dissolution Studies
10	Module 10: Change Control and Risk Management
11	Module 11: Documentation and Regulatory Submissions
12	Module 12: Technology Transfer and Lifecycle Management
13	Module 13: Practical Workshops and Case Studies

#	Outcomes
	• Explain the purpose and scope of SUPAC guidelines.
	• Differentiate between minor, moderate, and major post-approval changes.
	• Identify changes requiring regulatory notification, supplements, or approval.
	• Evaluate formulation, process, equipment, and site changes.
	• Apply SUPAC principles to scale-up and manufacturing changes.
	• Determine appropriate stability and dissolution requirements.
	• Prepare documentation supporting post-approval change submissions.
	• Conduct risk assessments for product and process changes.
	• Support regulatory compliance during product lifecycle management.
	• Manage changes while maintaining product quality and consistency.

#	Participants
1	� • Regulatory Affairs professionals
2	� • Research and Development (R&D) Scientists
3	� • Formulation Development Scientists
4	� • Process Development Engineers
5	� • Manufacturing Engineers
6	� • Quality Assurance (QA) personnel
7	� • Quality Control (QC) personnel
8	� • Validation Specialists
9	� • Technology Transfer Teams
10	� • Production Managers and Supervisors
11	� • Change Control Coordinators
12	� • Pharmaceutical and Biotechnology professionals
13	� • Professionals involved in product lifecycle management and regulatory submissions