| Day 1 |
|
| 8.00 –
8.30 |
Welcome, Presentation of the Speaker and the Delegates, Training
Schedule |
| 8.30 –
10.00 |
Regulatory Requirements for the Manufacturing of the Active
Pharmaceutical Ingredients
- Structure of the Regulations
- Europe
- USA
- Harmonisation
|
| 10.00
– 10.15 |
Break |
| 10.15
– 12.15 |
The
Quality Management System
- Regulatory Requirements
- FDA New View on QA-System
- Maintenance of a QA-System
- Main Points of a QA System
-Responsibility of the management
- Change
- OOS
- Deviation
- Complaints
- Training
- Communication with the Contractor
|
| 12.15
– 13.15 |
Lunch |
| 13.15
– 14.30 |
Risk
Management, ICH Q 9
- Methods, Content of ICH Q 9
- Performance
- Documentation
- Input on QA-System
- DIN EN ISO 14971
|
| 14.30
– 16.30 |
Qualification/Validation
- Regulatory Requirements
- Qualification of Equipment
- Documentation of Qualification
- Retrospective Qualification
- Requalification
- Cleaning Validation
- Validation of Processes
- Documentation of Validation
- Retrospective Validation
- Revalidation
|
| 15.30
– 15.45 |
Break
(in between) |
| 16.00
– 17.30 |
Quality Control
- Regulatory Requirements
- Duties of QA based on GMP-Guideline
- Performance of Testing
- QC/QA versus Qualified Person
- Validation of Analytical Methods
- Stability / Retest
|
| 17.30
– 18.00 |
Final
Discussion |
| |
|
| Day 2
|
|
| 8.00 –
8.30 |
Remarks, Questions; Proposals |
| 8.30 –
9.30 |
Facility and Material Management
- Qualification of Suppliers
- Supervision of Suppliers
- Maintenance of Equipment
- Internal
- External
- Control of Incoming Materials
- Storage
|
| 10.30
– 10.45 |
Break |
| 10.45
– 12.45 |
Manufacturing of the API
- Requirements for Manufacturing
- Starting Materials
- In Process Controls
- PAT (Process Analytical Technology)
- Mixing up of Different Batches
- Reprocessing
- Rework
|
| 12.45
– 13.45 |
Lunch |
| 13.45
– 14.45 |
GMP in
Research and Development
- Requirements for a Quality Management System
- Implementing of a Quality Management System
- Documentation
- CTD
- DMF
|
| 14.45
- 16.00 |
Documentation
- Regulatory Requirements
- Documentation of the QA System
- Documentation in
- Production
- Quality Control
- Engineering
- Quality Unit
- Annual Product Review
|
| 15.15
– 15.30 |
Break
(in between) |
| 16.00
– 17.15 |
Auditing and Self- Inspection
- Regulatory Requirements
- Auditprogram
- Auditplan
- Performance of Auditing
- Supervision of Contract Manufacturer
- Supervision of Manufacturer for Starting Materials
- Nuts and Bols of an Audit
|
| |
17.15
– 17.45 Discussion |
