| When |
What |
| 8.30 - 8.45 |
Welcome and Introduction
of Participants |
| 8.45 - 9.45 |
Basic Items of
Qualification - Guidelines, Glossary
|
| 9.45 - 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 |
19-20 June 2013 