| When |
What |
| 08.30 –
08.45 h |
Welcome |
| 08.45 –
09.45 h |
Quality
Data in CTD Module 2 and Module 3 |
| 09.45 –
10.45 h |
CTD Modul
3 Quality Drug Substance – What is required? |
| 10.45 –
11.15 h |
Coffee
Break |
| 11.15 –
12.15 h |
Advantage
for the API Manufacturer (1): CEP |
| 12.15 –
13.15 h |
Lunch
Break |
| 13.15 –
14.15 h |
Advantage
for the API Manufacturer (2): ASMF |
| 14.15 –
14.45 h |
Coffee
Break |
| 14.45 –
15.45 h |
CTD
Module 2: Quality Overall Summary |
| 15.45 –
16.30 h |
QP-Declaration in CTD Module 1: Auditing API Manufacturers |
| 16.30 –
17.00 h |
Final
Discussion |
| ca. 17.00
h |
End of
Training Course |
