This course provides participants with a comprehensive understanding of production operations in pharmaceutical, biotechnology, medical device, food, cosmetics, and other regulated manufacturing industries. It focuses on the planning, execution, monitoring, and control of manufacturing activities to ensure products are consistently produced according to approved specifications, Good Manufacturing Practices (GMP), and quality management system requirements.
Created by Dr. YASSER MEKKY
EN/AR [Auto]
Join Now| # | Content |
|---|---|
| 1 | Module 1: Introduction to Production Operations |
| 2 | Module 2: GMP Requirements for Production |
| 3 | Module 3: Production Planning and Scheduling |
| 4 | Module 4: Material Management in Production |
| 5 | Module 5: Equipment and Facility Management |
| 6 | Module 6: Manufacturing Process Control |
| 7 | Module 7: In-Process Controls |
| 8 | Module 8: Contamination Prevention |
| 9 | Module 9: Documentation and Batch Records |
| 10 | Module 10: Deviations, Change Control, and CAPA |
| 11 | Module 11: Health, Safety, and Environmental Controls |
| 12 | Module 12: Performance Monitoring and Continuous |
| 13 | Module 13: Practical Workshops and Case Studies |
| # | Outcomes |
|---|---|
| • Explain the stages of the manufacturing process from material dispensing to finished product. | |
| • Perform production activities in accordance with GMP and approved procedures. | |
| • Operate production equipment safely and effectively. | |
| • Apply Good Documentation Practices (GDP) during production. | |
| • Conduct line clearance and production startup activities. | |
| • Monitor and document critical process parameters. | |
| • Identify production deviations and initiate appropriate investigations. | |
| • Coordinate effectively with QA, QC, Warehouse, Engineering, and Maintenance departments. | |
| • Improve production efficiency while maintaining product quality. | |
| • Demonstrate readiness for internal and regulatory inspections. |
| # | Participants |
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| 1 |
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• Production Operators and Technicians
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| 2 |
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• Production Supervisors and Managers
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• Manufacturing Engineers
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• Quality Assurance (QA) personnel
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• Quality Control (QC) personnel
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• Process Engineers
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| 7 |
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• Engineering and Maintenance personnel
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| 8 |
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• Warehouse and Materials Management staff
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| 9 |
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• Validation and Compliance professionals
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• Packaging personnel
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| 11 |
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• Regulatory Affairs professionals
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| 12 |
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• Internal Auditors
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• Pharmaceutical, Biotechnology, Medical Device, Food, Cosmetics, and Chemical industry professionals
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| 14 |
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• Anyone involved in manufacturing and production operations
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