Computer System Validation (CSV) Basic Training
Date:
May 14, 2024 8:00 a.m. – 11:00 a.m.
May 15, 2024 8:00 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.
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 coaches:
Jakub Grzanka
Professional CSV consultant at wega Informatik AG with more than 10 years of experience in the pharmaceutical industry and CSV. As a biotechnologist, he began his career in a cell therapy laboratory in the United States, working in compliance with FDA regulations. In his home country of Poland, he worked in the pharmaceutical industry, where he successfully supported both small projects and large pharmaceutical companies. Jakub provides strategic end-to-end validation planning and oversight, guidance on the planned test activities, and documentation of the test approach; he ultimately ensures that all validation activities and results are complete and in compliance with company policies and procedures. During his brief career in CSV, he has successfully supported projects in various pharmaceutical departments—such as manufacturing, R&D, regulatory affairs, QC, and QA—while serving in a variety of roles. In addition, Jakub has been offering basic and advanced Computerized Systems Validation training courses for the past two years.
Dr. Andreas Wicki
Andreas Wicki is a 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 a 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.
Robert Dikti
Quality-oriented Junior CSV Consultant with a solid educational background. Over the past two years, I have been actively growing and developing my skills by leading multiple pharmaceutical IT projects; as a natural progression and part of my ongoing professional development, I have recently served as a facilitator for CSV training sessions. Previously served as a veterinary office manager and veterinary surgeon for 8 years, including managing a team of support staff and maintaining the highest quality of services on a daily basis by caring for the health and welfare of animals, always prioritizing human health and quality.
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