Charisma

#	Content
1	Module 1: Introduction to Reprocessing and Reworking
2	Module 2: Identification and Classification of Materials
3	Module 3: Evaluation and Risk Assessment
4	Module 4: Reprocessing Controls
5	Module 5: Reworking Controls
6	Module 6: Documentation and Traceability
7	Module 7: Quality Assurance and Regulatory Considerations
8	Module 8: Handling and Storage
9	Module 9: Deviations, Investigations and CAPA
10	Module 10: Practical Application

#	Outcomes
	• Define and differentiate reprocessing and reworking activities.
	• Identify materials and products that may require reprocessing or reworking.
	• Assess potential risks associated with reprocessing and reworking.
	• Apply appropriate procedures for handling and controlling reprocessed/reworked materials.
	• Maintain proper identification and traceability throughout the process.
	• Understand the importance of quality assessment and authorization before reuse or further processing.
	• Recognize situations where reprocessing or reworking may not be appropriate.
	• Complete and maintain relevant documentation and records.
	• Support investigations and corrective actions related to reprocessing and reworking activities.
	• Ensure that reprocessed or reworked materials meet applicable quality requirements before release.

#	Participants
1	� • Production Managers and Supervisors
2	� • Production Officers and Operators
3	� • Quality Assurance (QA) Professionals
4	� • Quality Control (QC) Professionals
5	� • Manufacturing and Process Engineers
6	� • Warehouse and Materials Management Personnel
7	� • Validation Professionals
8	� • Regulatory Affairs Professionals
9	� • GMP Compliance Personnel
10	� • Pharmaceutical and Biotechnology Professionals
11	� • Professionals involved in material and product disposition