Art-No.: A-1024
Date: 26-29 March 2019
Price: EUR 380,-
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 |