Training Content Outline  
Training Format: Approximately 32 hours of coursework + Case Studies  
**Part 1: Audit Management under MAH System**  
1. Audit Responsibilities of the Marketing Authorization Holder (MAH)  
2. Compliance Requirements for MAH Audits  
3. How the MAH Audits CMO Factories  
4. How the MAH Audits Raw Material and Excipient Suppliers  
5. How the MAH Conducts Self-Audits  
**Part 2: Key Elements and Processes of Self-Audits and Audits**  
1. Types and Management Processes of Self-Audits/Internal Audits  
2. Annual Self-Audit Plan  
3. Self-Audit/Internal Audit Teams and Personnel  
4. Execution of Self-Audits/Internal Audits and Key Considerations  
5. Records and Reporting for Self-Audits/Internal Audits  
6. Common Issues and Improvement Solutions in Self-Audits/Internal Audits  
7. Case Studies of Routine Self-Audits  
**Part 3: Key Points in Quality Management System Audits**  
1. Compliance Requirements for Quality Assurance Systems  
2. Audit of Quality Management Documentation Systems  
3. Organizational Structure, Personnel, and Training Management  
4. Risk-Based Validation Management and Validation Audits  
5. Audits of User Complaints, Product Returns, and Recalls  
6. Common Deficiencies and Case Studies in Quality Assurance System Audits  
7. Audit of Commissioning Production Quality Management Systems  
**Part 4: Key Focus and Common Issues in Material System Self-Audits and Audits**  
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 Product Returns  
5. Common Deficiencies in Material Management Systems  
**Part 5: Key Audit Focus and Deficiencies in QC System Self-Audits**  
1. QC System Self-Audit Workflow  
2. Human Factors Audit Focus and Deficiencies  
3. Equipment Factors Audit Focus and Deficiencies  
4. Material Factors Audit Focus and Deficiencies  
5. Method Factors Audit Focus and Deficiencies  
6. Environmental Factors Audit Focus and Deficiencies  
**Part 6: Key Focus and Precautions in Production System Self-Audits and Audits**  
1. Risk Assessment and Production Management in Shared-Line Production  
2. Data Authenticity and Traceability in Production Processes  
3. Operability and Consistency of Production Documents  
4. Evaluation and Output of Critical Process Parameters and Quality Attributes  
5. Principles of Material Grade Evaluation and Transfer Processes  
6. Process Transfer, Technical Transfer, and Evolution of Process Parameters  
7. Environmental Monitoring Location Verification and Statistical Analysis of Test Data  
8. Management of Process Validation or Continued Process Verification  
9. Personnel Training and Operational Compliance  
**Part 7: Key Focus and Requirements in Facility and Equipment System Self-Audits**  
1. Management Requirements for Overall Plant Infrastructure  
2. Audit Requirements for Utility Systems  
3. Audit Requirements for Cleanroom Hardware  
4. General Audit Requirements for Equipment Systems  
5. Maintenance and Care of Equipment  
6. Calibration Requirements for Instruments and Meters  

7. Common Issues in Plant Infrastructure and Equipment Systems

VIII. Special Self-Inspection and Audit Focus Areas for Data Reliability  
1. Global developments and trend analysis in data reliability regulations  
2. PIC/S special considerations for data integrity in computerized systems  
3. Data integrity requirements for laboratory systems and production systems  
4. Audit focus areas for data integrity and common issues in laboratories