Charisma

#	Content
1	Module 1: Introduction to Batch Records
2	Module 2: Regulatory Requirements
3	Module 3: Master Batch Records (MBRs)
4	Module 4: Completed Batch Records (CBRs)
5	Module 5: Good Documentation Practices (GDP)
6	Module 6: Batch Record Review
7	Module 7: Deviations and Change Control
8	Module 8: Electronic Batch Records (EBRs)
9	Module 9: Batch Traceability
10	Module 10: Inspection Readiness
11	Module 11: Record Management
12	Module 12: Practical Workshops and Case Studies

#	Outcomes
	• Explain the structure and purpose of Master Batch Records and Completed Batch Records.
	• Prepare accurate and standardized Master Batch Records.
	• Record manufacturing and packaging activities according to GMP requirements.
	• Apply Good Documentation Practices throughout batch record completion.
	• Maintain complete traceability of materials, equipment, operators, and process parameters.
	• Review batch records for completeness, accuracy, and compliance.
	• Identify documentation errors and implement appropriate corrections.
	• Support product release through proper batch record documentation.
	• Utilize electronic batch record systems effectively.
	• Demonstrate inspection readiness by maintaining compliant documentation.

#	Participants
1	� • Production Operators and Technicians
2	� • Production Supervisors and Managers
3	� • Quality Assurance (QA) personnel
4	� • Quality Control (QC) personnel
5	� • Documentation Specialists
6	� • Validation and Compliance professionals
7	� • Manufacturing Engineers
8	� • Packaging personnel
9	� • Warehouse and Materials Management staff
10	� • Regulatory Affairs professionals
11	� • Internal Auditors
12	� • Pharmaceutical, Biotechnology, Medical Device, Cosmetics, Food, and Chemical industry professionals
13	� • Anyone responsible for preparing, completing, reviewing, or approving batch documentation