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Supplier and contractor qualification

• This course provides participants with the knowledge and practical approaches required to qualify, evaluate, approve, and monitor suppliers and contractors in accordance with GMP and quality management system requirements. It covers supplier and contractor qualification processes, risk assessment methodologies, audit practices, performance monitoring, and regulatory expectations to ensure that outsourced activities and supplied materials consistently meet quality standards and compliance requirements.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 Module 1: Introduction to Supplier and Contractor Qualification
2 Module 2: Supplier Selection and Qualification Process
3 Module 3: Risk Assessment and Classification
4 Module 4: Supplier and Contractor Audits
5 Module 5: Quality Agreements and Contracts
6 Module 6: Supplier Performance Monitoring
7 Module 7: Requalification and Change Management
8 Module 8: Documentation and Regulatory Compliance
9 Module 9: Case Studies and Practical Exercises
# Outcomes
• Define the roles and responsibilities involved in supplier and contractor qualification.
• Develop and implement supplier qualification procedures.
• Perform supplier and contractor risk assessments.
• Evaluate supplier documentation and quality systems.
• Conduct supplier audits and interpret audit findings.
• Monitor supplier performance using quality metrics and key performance indicators.
• Manage requalification activities and supplier change controls.
• Ensure compliance with GMP and quality management requirements.
# Participants
1
• Quality Assurance (QA) professionals.
2
• Quality Control (QC) personnel.
3
• Procurement and Purchasing staff.
4
• Supply Chain and Warehouse professionals.
5
• Manufacturing and Production personnel.