1.0 Contract Manufacturing Overview
1.1 System and responsibility
2.0 Process for approving contract manufacturers
2.1 Overall strategy
2.2 Identification of contract manufacturers
2.3 Evaluation and selection of contract manufacturers
2.4 Approval for technology transfer
2.5 Implementation of contract manufacturing
2.6 Quality authorization of contract manufacturing operations
2.7 Ongoing quality management and oversight
2.8 Ongoing quality management and changes
3.0 Main Business Agreement
3.1 Required quality elements in the main business agreement
4.0 Quality Agreement
4.1 Requirement for quality agreements
4.2 Regulatory requirements
4.3 Personnel
4.4 Documentation
4.5 Manufacturing facilities
4.6 Validation
4.7 Operations
4.8 Materials management
4.9 Rework, reprocessing and rejected material
4.10 Quality
4.11 Laboratory
4.12 Batch release
4.13 Labeling and printed packaging material control
4.14 Storage and shipping operation
4.15 Product complaints
4.16 Annual product review
4.17 Attachments to the quality agreement
4.18 Periodic review of the quality agreement
| Duration | 3 days |
| Language | English |
| Participants | 8 - 15 |
| Fees |