| 8.00 - 8.30 |
Welcome, Introduction,
Presentation of the Speaker |
| 8.30 - 9.30 |
Regulations in Europe
- Directives
- Guidelines
- Notices
Regulations in the USA
Harmonised Regulations
|
| 9.30 - 10.45 |
GMP in Manufacturing
- Quality of Starting Material
- Production Process
- Packaging and Storage
- Contract Manufacturing
- Responsibility
|
| 10.45 - 11.00 |
Break
|
| 11.00 - 12.15 |
GMP in Quality Control
- Duties of Quality Control
- Differences Between Europe And USA
- Qualified Person
- Validation of Analytical Methods
- Performance of Analytical Methods
|
| 12.15 - 13.15 |
Lunch
|
| 13.15 - 14.30 |
Documentation
- SOPs
- Batch Documentation
- Quality Control Documentation
- GMP-Based Documentation
- GMP Relevant Documents
- Archiving
|
| 14.30 - 14.45 |
Break
|
| 14.45 - 15.45 |
Qualification and Validation
- Definition and Differences
- Validation Master Plan
- Validation Team/Performance of Validation
- Responsibilities
|
| 15.45 - 16.45 |
Change Management
- Deviation
- Change
- Definition and Differences
- Out of Specification
- SOP
|
| 16.45 - 17.15 |
Training and Self-Inspection
- Performance of Training
- Performance of Self-Inspections
- SOP
- Documentation
|
