Charisma

#	Content
1	Module 1: Introduction to Validation and Qualification
2	Module 2: Regulatory Requirements
3	Module 3: Qualification and Validation Fundamentals
4	Module 4: Validation Master Plan (VMP)
5	Module 5: Qualification Preparation and Execution
6	Module 6: Equipment Qualification Case Study
7	Module 7: Process Validation (PV)
8	Module 8: Analytical Method Validation (AMV)
9	Module 9: Shipping Validation
10	Module 10: Revalidation and Continuous Evaluation

#	Outcomes
	• Interpret international qualification and validation guidelines.
	• Explain lifecycle validation concepts in pharmaceutical manufacturing.
	• Plan and execute qualification protocols for facilities, utilities, equipment, and systems.
	• Develop validation documentation including protocols, reports, and Validation Master Plans.
	• Perform Process Validation (PV) using a lifecycle approach.
	• Apply Analytical Method Validation (AMV) requirements and validation characteristics.
	• Evaluate shipping and supply chain validation requirements.
	• Conduct periodic evaluations and determine when revalidation is necessary.
	• Integrate quality risk management and knowledge management into validation activities.
	• Support regulatory inspections through compliant validation documentation

#	Participants
1	� • Validation engineers
2	� • Qualification engineers
3	� • Quality Assurance (QA) personnel
4	� • Quality Control (QC) professionals
5	� • Production managers and supervisors
6	� • Engineering and maintenance personnel
7	� • Automation and computerized systems engineers
8	� • Pharmaceutical development scientists
9	� • Technology transfer teams
10	� • Regulatory Affairs professionals
11	� • GMP auditors
12	� • Pharmaceutical manufacturing professionals involved in validation and qualification activities