| 08.30 - 08.45 | Welcome and Introduction of Participants |
| 08.45 - 09.45 | Basic Items of Qualification - Guidelines, Glossary |
| 09.45 - 10.15 | Validation Master Plan |
| 10.15 - 10.45 | Break |
| 10.45 - 11.15 | Risk Analysis |
| 11.15 - 12.00 | User Requirement Specification (URS), Functional Design Specification (FDS), Design Qualification (DQ) |
| 12.00 - 13.00 | Lunch |
| 13.00 - 13.15 | FAT/SAT |
| 13.15 - 13.45 | Installation Qualification (IQ) |
| 13.45 - 14.15 | Operational Qualification (OQ), Performance Qualification (PQ) |
| 14.15 - 14.30 | Break |
| 14.30 - 15.15 | Workshop |
| 15.15 - 15.45 | Presentation and Discussion of Workshop Results |
| 15.45 - 16.15 | Process Validation |
| 16.15 - 16.45 | Maintaining the Validated Status |