Computer System Validation (CSV) Basic Training
Date:
November 23, 2022 8:30 a.m. – 11:00 a.m.
November 24, 2022 8:30 a.m. – 11:00 a.m.
Virtual Event:
Language:
Fee:
Registration via the contact form
The event will be held in English
CHF 800, including a training certificate
Introduction
This course provides an introduction and overview of computer-supported system validation (CSV), as well as the applicable laws and regulations. You will learn about the typical scope of documentation and the GAMP5 approach. In addition, the course offers an overview of current and future trends, such as data integrity, agile validation, cloud computing, and computer software assurance.
The CSV Advanced Training will take place in the first quarter of 2023.
Agenda
- Introduction - Participants' Expectations
- Laws and Regulations in the CSV
- The GAMP Approach to CSV
- The Elements of Computer Validation (Stages and Phases)o Supplier Managemento Validation Planning and Reporting
o Supplier Management
o Validation Planning and Reporting
o User Requirements
o Functional, configuration, design, and module specifications
o Risk Management
o System Architecture
o Testing/Verification - Phases, Handling Deviations
o Traceability of requirements
o System Migration - SOPs, Business Continuity, Training
o System Operations - Change and Configuration Management, Periodic Reviews
o System Shutdown
- Questions and Answers
Details
- Managers or employees in the regulated CSV environment (GxP)
Training:
- 1 day divided into two 4-hour meetings via MS Teams
- Up to 12 participants per session
- CHF 800, including a training certificate
- training@wega-it.com
- Phone: +41 61 270 87 87
- or using the contact form below
Our Coach:
Dr. Andreas Wicki
Senior CSV Consultant at wega Informatik AG with more than 20 years of experience in the pharmaceutical industry and CSV. As a trained organic chemist and former CSV QA specialist at a pharmaceutical company, Andreas Wicki is very familiar with both worlds—laboratory, production, supply chain, QA processes, and IT requirements and needs. This enables Andreas to bridge the gap between business and IT. In recent years, he has worked in various roles on many successful validation projects, ranging from smaller-scale to highly complex ones.
Register here
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