Charisma

#	Content
1	Module 1: Introduction to Pharmaceutical Regulations
2	Module 2: Global Regulatory Authorities
3	Module 3: Good Manufacturing Practice (GMP)
4	Module 4: International Guidelines
5	Module 5: Pharmaceutical Quality Systems
6	Module 6: Documentation and Data Integrity
7	Module 7: Regulatory Compliance
8	Module 8: Validation and Qualification Requirements
9	Module 9: Risk Management
10	Module 10: Regulatory Inspections and Audits
11	Module 11: Product Lifecycle Regulatory Requirements
12	Module 12: Regulatory Submissions
13	Module 13: Current Trends in Pharmaceutical Regulations
14	Module 14: Case Studies and Practical Applications

#	Outcomes
	• Explain the purpose of pharmaceutical regulations and guidance documents.
	• Identify the responsibilities of major regulatory agencies.
	• Interpret the requirements of GMP and related international guidelines.
	• Apply regulatory expectations to manufacturing, laboratory, and quality operations.
	• Recognize compliance risks and implement preventive actions.
	• Support inspection readiness and regulatory compliance.

#	Participants
1	� • Quality Assurance (QA) Professionals
2	� • Quality Control (QC) Analysts
3	� • Production and Manufacturing Personnel
4	� • Validation and Qualification Engineers
5	� • Regulatory Affairs Professionals
6	� • Research and Development (R&D) Staff
7	� • Engineering and Maintenance Personnel
8	� • Warehouse and Supply Chain Personnel
9	� • Documentation Specialists
10	� • Laboratory Personnel
11	� • Pharmaceutical Supervisors and Managers
12	A Anyone involved in GMP-regulated pharmaceutical operations