| 8.00 - 8.30 |
Welcome,
Introduction, Presentation of the Speaker |
| 8.30 - 9.30 |
Regulations and
Requirements
- Europe
- FDA
- Harmonised Requirements
|
| 9.30 - 10.30 |
Content of the ISO
Norms
- ISO 9001
- ISO 13485
- Applicable Norms
|
| 10.30 - 10.45 |
Break |
| 10.45 - 11.45 |
ISO versus GMP
- Requirements of ISO
- Requirements of GMP
- Common and differences of ISO -
GMP
- Advantages of a combined system
|
| 11.45 - 12.45 |
Implementation and
Maintenance of the Quality Assurance System
- Quality Unit
- Quality System
- Definition of the requirements
for the Quality Unit
- Supervision of the
system/requirements
|
| 12.45 - 13.45 |
Lunch |
| 13.45 - 14.45 |
CFR 800 as a
Practical Approach for Combination of GMP and ISO
- Content of CFR 800
- QSR
- QSIT
- Quality manual
|
| 14.45 - 15.00 |
Break |
| 15.00 - 16.00 |
Documentation of the
Quality System
- SOPs
- Quality policy
- Quality manual
- QA documents in general
|
| 16.00 - 17.00 |
Documentation and
Archiving
- Requirements for documentation
and archiving
- Time for archiving
|
| 17.00 - 17.30 |
Discussion |
