ECA - Computer Validation: Introduction to Risk Management / The GAMP 5 Approach
Art-No.: A-1024
Date: 26-29 March 2019
Price: EUR 380,-
The Conference folder includes the following topics:
| No. | Topic | Summary | Pages |
| 12884 | Introduction | 0 | 13 |
| 12885 | An Introduction to RM | 0 | 46 |
| 12886 | RM the GAMP 5 Way | 0 | 55 |
| 12887 | WS: Risk Assessment in Validation | 0 | 5 |
| 12888 | WS: Risk Management in Validation | 0 | 4 |
| 12889 | An Introduction to Risk Ranking | 0 | 28 |
| 12890 | WS 3: Applying Risk Ranking to determine Periodic Review Priorities | 0 | 3 |
| 12891 | Assessing and Selecting a supplier | 0 | 37 |
| 12892 | WS4: Assessing and Selecting a supplier | 0 | 3 |
| 12893 | The GAMP5 Approach: Welcome and Introduction | 0 | 19 |
| 12894 | Laws, Regulations and Guidelines for CV | 0 | 18 |
| 13282 | The EU Annex 11Computerised Systems | 0 | 42 |
| 13283 | WS: Self Evaluation of comliance with Annex11 | 0 | 15 |
| 13284 | The GAMP 5 Approach to CV | 0 | 44 |
| 13285 | Introduction to requirements | 0 | 12 |
| 13286 | WS - Evaluation of a user requirement specification | 0 | 6 |
| 13287 | RM: A key Point Review | 0 | 54 |
| 13289 | Validation Planning/ Validation Documentation | 0 | 45 |
| 13290 | WS: Validation Planning | 0 | 4 |
| 13291 | Specification, Design Review and Traceabilities | 0 | 32 |
| 13292 | WS: RM in Protocol Planning | 0 | 8 |
| 13293 | Protocols, Test Scipts and Deviation Management | 0 | 31 |
| 13294 | WS: Managing Deviations | 0 | 3 |
| 13295 | Principles of Change Management | 0 | 30 |
| 13296 | WS: Change Control | 0 | 3 |
| 13297 | Automation Aspects | 0 | 0 |
| 13298 | Validation Reporting | 0 | 21 |
| 13299 | Presentation to Inspectors | 0 | 24 |
| 13300 | Intro to IT Infrastructure Qualification | 0 | 0 |
| 13301 | Regulatory Comments | 0 | 37 |
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