| When |
What |
| 8.00 - 8.30 |
Welcome,
Introduction, Presentation of the Speaker |
| 08.30 - 09.30 |
GMP-Regulations and
GMP-Requirements Applying to a QA Unit
- Europe
- FDA
- Harmonised Requirements
|
| 09.30 - 10.30 |
ISO versus GMP
- Requirements of ISO
- Requirements of GMP
- Common and differences of ISO -
GMP
- Advantages of a combined system
|
| 10.30 - 10.45 |
Break
|
| 10.45 - 11.45 |
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
|
| 11.45 - 12.45 |
Documentation of the
Quality System
- SOPs
- Quality policy
- Quality manual
- QA documents in general
|
| 12.45 - 13.45 |
Lunch
|
| 12.45 - 13.45 |
Elements of a Quality
Assurance System
- Qualification / validation
- OOS
- Deviation / Change control
- Auditing
- Training etc.
|
| 13.45 - 14.45 |
Break
|
| 15.00 - 16.00 |
QA-System in Research
and Development
- QA system in research
- QA system in development
- Project management
- Connection of R. A. D. to
production
|
| 16.00 - 16.30 |
Documentation and
Archiving
- Requirements for documentation
and archiving
- Time for Archiving
|
| 16.30 - 17.00 |
QA Unit versus
Qualified Person
- EC requirements for qualified
person
- Duties and responsibilities of
the qualified person
- Qualified person and FDA
requirements
|
| 17.00 - 17.30 |
Discussion |
19-20 June 2013 