Charisma

#	Content
1	Module 1: Introduction to Critical Unit Processes
2	Module 2: Identification of Critical Process Parameters
3	Module 3: Risk Assessment
4	Module 4: Requirements for Critical Process Control
5	Module 5: Equipment and Facility Requirements
6	Module 6: Process Validation
7	Module 7: Monitoring and Documentation
8	Module 8: Deviations and Change Control
9	Module 9: Quality and GMP Requirements
10	Module 10: Practical Application

#	Outcomes
	• Define critical unit processes and explain their importance.
	• Identify critical process parameters and quality attributes.
	• Evaluate risks associated with critical manufacturing operations.
	• Apply appropriate controls to critical process steps.
	• Monitor and document critical process parameters.
	• Recognize process deviations and understand their potential impact on product quality.
	• Understand the role of validation and qualification in critical processes.
	• Maintain appropriate documentation and traceability.
	• Support investigations and CAPA activities related to critical process deviations.
	• Contribute to maintaining consistent and compliant manufacturing processes.

#	Participants
1	� • Production Managers and Supervisors
2	� • Production Officers and Operators
3	� • Process and Manufacturing Engineers
4	� • Quality Assurance (QA) Professionals
5	� • Quality Control (QC) Professionals
6	� • Validation Professionals
7	� • Maintenance and Engineering Personnel
8	� • GMP Compliance Professionals
9	� • Regulatory Affairs Professionals
10	� • Pharmaceutical and Biotechnology Professionals
11	� • Personnel involved in process monitoring and control