Training Mode: Approximately 32 hours of training + Case Analysis
I. Audit Management under MAH System
1. Audit Responsibility of Holders
2. Compliance Requirements for Holder Audits
3. How Holders Audit CMO Facilities
4. How Holders Audit Raw Material and Excipient Suppliers
5. Self-inspection Practices for Holders
II. Elements and Processes of Self-inspection and Audit
1. Types and Management Process of Self-inspection/Internal Audit
2. Annual Self-inspection Plan
3. Self-inspection/Internal Audit Team and Personnel
4. Execution of Self-inspection/Internal Audit and Key Considerations
5. Records and Reporting for Self-inspection/Audit
6. Common Issues in Self-inspection/Audit and Improvement Solutions
7. Case Analysis of Routine Self-inspection
III. Key Audit Points in Quality Management Assurance System
1. Compliance Requirements for Quality Assurance Systems
2. Audit of Quality Management Documentation System
3. Organizational Structure, Personnel, and Training Management
4. Risk-based Validation Management and Validation Audit
5. Audit of User Complaints, Returns, and Recalls
6. Common Defects and Case Analysis in Quality Assurance System Audit
7. Audit of Commissioned Production Quality Management System
IV. Key Focus and Common Issues in Material System Self-inspection and Audit
1. Supplier Qualification Verification
2. Material Acceptance (Inspection, Sampling, Release/Rejection, Periodic Re-evaluation)
3. Warehouse Control (Inventory Management, Material Issuance, Temperature/Humidity Control)
4. Management of Non-conforming Materials and Returns
5. Common Defects in Material Management System
V. Key Audit Focus and Defect Analysis in QC System Self-inspection
1. QC System Self-inspection Process
2. Human Factor Audit Focus and Defects
3. Equipment Factor Audit Focus and Defects
4. Material Factor Audit Focus and Defects
5. Method Factor Audit Focus and Defects
6. Environmental Factor Audit Focus and Defects
VI. Key Focus and Considerations in Production System Self-inspection and Audit
1. Risk Assessment and Production Management in Co-line Production
2. Data Authenticity and Traceability in Production Processes
3. Operability and Consistency of Production Documents
4. Critical Process Parameters, Critical Quality Attributes Evaluation
5. Material Grade Evaluation Principles and Transfer Process
6. Process/Technology Transfer and Parameter Evolution
7. Environmental Monitoring Location Confirmation and Data Statistical Analysis
8. Process Validation or Continued Process Verification Management
9. Personnel Training and Operational Compliance
VII. Key Focus and Requirements in Facilities and Equipment System Self-inspection
1. Management Requirements for Overall Plant Infrastructure
2. Inspection Requirements for Utility Systems
3. Inspection Requirements for Cleanroom Hardware
4. General Inspection Requirements for Equipment Systems
5. Maintenance and Preservation of Equipment
6. Calibration Requirements for Instruments and Equipment
7. Common Defect Analysis in Facilities and Equipment Systems
VIII. Key Points for Data Reliability Special Self-Inspection and Audit
1. Global Developments and Trend Analysis in Data Reliability Regulations
2. PIC/S Special Data Integrity Considerations for Computerized Systems
3. Data Integrity Requirements for Laboratory Systems and Production Systems
4. Audit Focus on Data Integrity and Common Issues in Laboratories
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Editor in charge：Shanghai Yue Fei Enterprise Management Consulting Co., Ltd.
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