| When |
What |
| |
Schedule Day 1 |
| 09.00 - 09.30 h |
Introduction to the Annex 11 Course |
| 09.30 - 11.00 h |
Identifying the Main Changes to GMP
Annex 11 for Computerised Systems |
| 11.00 - 11.30 h |
Coffee Break |
| 11.30 - 12.15 h |
Annex 11 Principles and Risk Management |
| 12.15 - 13.00 h |
Roles and Responsibilities in
Computerised System Validation |
| 13.00 - 14.00 h |
Lunch
Break |
| 14.00 - 15.15 h |
Workshop 1: Assessing the Impact of the
New Validation Section of Annex 11 |
| 15.15 - 15.30 h |
Coffee
Break |
| 15.30 - 16.00 h |
EU GMP Annex 11 Electronic Signatures |
| 16.00 - 16.45 h |
Workshop 2: Electronic Signatures |
| 16.45 - 17.00 h |
Coffee Break |
| 17.00 - 17.30 h |
Inventory of Computerised Systems and
System Descriptions |
| 17.30 - 18.00 h |
New Requirements for Vendor Audits |
| 18.00 - 18.30 |
Final Discussion Day 1 |
| |
Schedule Day 2 |
| 08.30 - 09.30 h |
GMP Chapter 4 on Documentation: What
are the major changes? |
| 09.30 - 10.45 h |
Workshop 3: Implementing Chapter 4 and
Annex 11 Requirements for Electronic Records |
| 10.45 - 11.15 h |
Coffee Break |
| 11.15 - 12.00 h |
Data Integrity Requirements for
Computerised Systems |
| 12.00 - 12.30 h |
Regulatory Issues around the
Information Technology Department |
| 12.30 - 13.30 h |
Lunch Break |
| 13.30 - 14.15 h |
Security of Networks and Computerised
Systems |
| 14.15 - 15.00 h |
Batch Release |
| 15.00 - 15.15 h |
Coffee Break |
| 15.15 - 15.45 h |
Change Control and Configuration
Management |
| 15.45 - 16.15 h |
Periodic Evaluation of Computerised
Systems |
| 16.15 - 16.30 h |
Final Discussion |
