|
No. |
Topic |
Summary |
Pages |
8989
| Introduction | - | 14 |
8990
| Interactive Session: Good Validation Practices | - | 17 |
8991
| GAMP 5 overview | - | 37 |
8992
| Roles, Responsibilities and Governance | - | 42 |
8993
| Introduction to Writing Requirements | - | 10 |
8994
| Workshop: Writing a Requirements Specifications | - | 3 |
8995
| Advanced Risk Management | - | 36 |
8996
| Workshop: Application of GAMP Risk Management Methodology to a Control System (HVAC) | - | 4 |
8997
| Workshop: Application of GAMP Risk Management Methodology to a Computer System | - | 5 |
8999
| Design Specification, Design Review and Risk Mitigation | - | 27 |
9000
| Workshop: Risk Mitigation and Challenge Testing | - | 3 |
9001
| Validating Spreadsheets | - | 16 |
9002
| Scaleability of validation | - | 19 |
9003
| Workshop: Scaleability of validation | - | 2 |
9004
| Case Study - GAMP 5 approach | - | 37 |
9005
| Risk Management applied to Electronic Record Controls | - | 23 |
9007
| Code Review | - | 14 |
9008
| Change Control and Configuration Management | - | 18 |
9009
| Data Security/ Data Privacy | - | 19 |
9010
| Outsourcing | - | 27 |
9011
| Infrastructure Management/ ITIL | - | 50 |
9012
| Handover - the Process and Package | - | 22 |
10234
| Workshop: Implications of your organisation | - | 1 |
