Charisma

#	Content
1	Module 1: Introduction to Computerized Systems
2	Module 2: Regulatory Requirements
3	Module 3: Computerized System Lifecycle (CSL)
4	Module 4: Computerized System Validation (CSV)
5	Module 5: User Requirements and Risk Assessment
6	Module 6: Data Integrity
7	Module 7: Electronic Records and Electronic Signatures
8	Module 8: Security and Cybersecurity
9	Module 9: Change Control and Configuration Management
10	Module 10: Operation and Maintenance
11	Module 11: Vendor and Supplier Management
12	Module 12: Inspection Readiness
13	Module 13: Practical Workshops and Case Studies

#	Outcomes
	• Explain the role of computerized systems in quality management.
	• Differentiate between automated equipment and computerized systems.
	• Describe the computerized system lifecycle from planning through retirement.
	• Conduct GAMP-based risk assessments.
	• Develop User Requirement Specifications (URS).
	• Understand Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems.

#	Participants
1	� • Quality Assurance (QA) professionals
2	� • Quality Control (QC) personnel
3	� • Validation Engineers
4	� • Computer System Validation (CSV) Specialists
5	� • IT Professionals supporting GxP systems
6	� • Manufacturing and Production Engineers
7	� • Laboratory Managers and Analysts
8	� • Automation Engineers
9	� • Regulatory Affairs professionals
10	� • Engineering and Maintenance personnel
11	� • Pharmaceutical and Biotechnology professionals
12	� • Medical Device professionals
13	� • Auditors and Compliance Officers
14	� • Anyone responsible for computerized systems in regulated environments