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| 12.30 - 13.00 | Q & A session on major differences from the draft guidance |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