| 08.30 - 09.00 | Introduction / Expectation of the Participants / Aim of the Event / Annex 11 Overview |
| 09.00 - 09.30 | Annex 11 Inventory How to create a CSV compliant inventory |
| 09.30 - 10.15 | CSV Roles & Responsibilities, Risk Management |
| 10.15 - 10.30 | Morning coffee break |
| 10.30 - 11.00 | Electronic Signature Requirements Which areas must have an e-Sig? Batch release |
| 11.00 - 12.30 | Data Integrity Requirements How to get systems in the state of control to survive in-spections? |
| 12.30 - 13.15 | Lunch |
| 13.15 - 14.00 | Audit Trail and Audit Trail Review Pragmatic approach to ATR. Which capacity is needed? |
| 14.00 - 14.30 | Supplier Audits Risk based approach |
| 14.30 - 14.45 | Coffee break |
| 14.45 - 15.30 | IT Infrastructure Qualification Main elements to qualify |
| 15.30 - 16.00 | IT Security Requirements User administration, access control |
| 16.00 - 16.30 | CSV Findings during Health Authority Inspections |
| 16.30 - 17.00 | Q & A |