| Day 1
Schedule |
|
| 09.00 -
09.30 h |
Registration |
| 09.30 –
09.45 h |
Introduction to course |
| 09.45 -
10.30 h |
Abberant &
atypical results; OOS, OOE & OOT |
| 10.30 -
11.15 h |
Background
to FDA OOS guidance |
| 11.15 -
11.30 h |
Coffee
Break |
| 11.30 -
12.30 h |
FDA final
guidance |
| 12.30 -
13.00 h |
Q & A
session on major differences from the draft guidance |
| 13.00 -
14.00 h |
Lunch |
| 14.00 -
15.00 h |
Statistical aspects of OOS results |
| 15.00 -
17.00 h |
Workshop 1
on Laboratory OOS scenarios (includes afternoon break) |
| 17.00 –
17.30 h |
Q & A
session |
| |
|
| Day 2
Schedule |
|
| 09.00 -
09.45 h |
In
specification results and risk based CGMPs |
| 09.45 –
10.30 h |
Best
practices to reduce OOS results in the laboratory |
| 10.30 -
10.45 h |
Coffee
Break |
| 10.45 -
11.45 h |
Analytical
data quality management |
| 11.45 -
13.00 h |
Workshop 2
on trend analysis |
| 13.00 -
14.00 h |
Lunch |
| 14.00 -
15.00 h |
Conducting
Failure investigations |
| 15.00 -
17.00 h |
Workshop 3
Failure investigation (includes afternoon break) |
| 17.00 –
17.30 h |
Q & A
session and course wash up |
