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
12885An Introduction to RM046
12886RM the GAMP 5 Way055
12887WS: Risk Assessment in Validation05
12888WS: Risk Management in Validation04
12889An Introduction to Risk Ranking028
12890WS 3: Applying Risk Ranking to determine Periodic Review Priorities03
12891Assessing and Selecting a supplier037
12892WS4: Assessing and Selecting a supplier03
12893The GAMP5 Approach: Welcome and Introduction019
12894Laws, Regulations and Guidelines for CV018
13282The EU Annex 11Computerised Systems042
13283WS: Self Evaluation of comliance with Annex11015
13284The GAMP 5 Approach to CV044
13285Introduction to requirements012
13286WS - Evaluation of a user requirement specification06
13287RM: A key Point Review054
13289Validation Planning/ Validation Documentation045
13290WS: Validation Planning04
13291Specification, Design Review and Traceabilities032
13292WS: RM in Protocol Planning08
13293Protocols, Test Scipts and Deviation Management031
13294WS: Managing Deviations03
13295Principles of Change Management030
13296WS: Change Control03
13297Automation Aspects00
13298Validation Reporting021
13299Presentation to Inspectors024
13300Intro to IT Infrastructure Qualification00
13301Regulatory Comments037

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