#pharmaceutical #csv #csa #validation #quality #qrm #riskmanagement #fda #compliance #gmp #ich
This session will make you understand the "Quality Risk Management for Computerised Systems" requirements in line with the various guideline expectations for example - EUGMP annex 11, 21 CFR Part 11, GAMP5 guide etc.
The agenda for this session is as below;
Importance of topic
Know your Trainer
Purpose and Scope of CSV
QRM - Guideline Requirements in Computerised Systems
Quality Risk Management - Overview
Quality Risk Management - Practical Approach
Risk Management to Evaluate Potential Impact
Risk Management within the Validation Lifecycle
Q&A
Vote of Thanks and contact details
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