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Production operations

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.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# 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
1
• Production Operators and Technicians
2
• Production Supervisors and Managers
3
• Manufacturing Engineers
4
• Quality Assurance (QA) personnel
5
• Quality Control (QC) personnel
6
• Process Engineers
7
• Engineering and Maintenance personnel
8
• Warehouse and Materials Management staff
9
• Validation and Compliance professionals
10
• Packaging personnel
11
• Regulatory Affairs professionals
12
• Internal Auditors
13
• Pharmaceutical, Biotechnology, Medical Device, Food, Cosmetics, and Chemical industry professionals
14
• Anyone involved in manufacturing and production operations