Computer System Validation (CSV) Basic Training
Date:
September 24, 2024 08:00 - 11:00
September 25, 2024 08:00 - 11:00
Virtual event:
Language:
Fee:
Registration via the contact form
The event will be held in English
CHF 800 incl. training certificate
Introduction
This course provides an introduction and overview of computerized system validation (CSV) and the applicable laws and regulations. You will learn about the typical scope of documentation and the GAMP5 approach. In addition, the course also provides an overview of current and future trends, such as data integrity, agile validation, cloud computing, computer software assurance.
Agenda
- Introduction - Expectations of the participants
- Laws and regulations in the CSV
- The GAMP approach for CSV
- The elements of computer validation (stages and phases)
o Supplier managemento Validation planning and reporting
o User requirements
o Function, configuration, design and module specifications
o Risk management
o System structure
o Testing/verification - phases, dealing with deviations
o Traceability of the requirements
o System transition - SOPs, business continuity, training
o System operation - change and configuration management, periodic review
o System decommissioning
- Questions and answers
Details
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- Supervisors or employees from the regulated CSV environment (GxP)
Training:
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- 1 day divided into two meetings of 4 hours via MS Teams
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- Up to 12 participants per session
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- CHF 800 incl. training certificate
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- training@wega-it.com
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- Phone: +41 61 270 87 87
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- or with the contact form below
Our trainers:
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 started his work in a cell therapy laboratory in the United States under FDA regulations. In his country of origin, Poland, he worked in the pharmaceutical industry, successfully supporting small projects and large pharmaceutical companies. Jakub provides strategic end-to-end validation planning and oversight, validation guidance for the planned testing activities and documentation of the testing approach, and ultimately ensures that all validation activities and results are complete and in accordance with company policies and procedures. During his short CSV career, he successfully supported projects in various pharma departments, such as production, R&D, regulatory, QC and QA, working in different roles. In addition, Jakub has been providing basic and advanced Computerized Systems Validation training for 2 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 as a CSV QA in a pharmaceutical company, Andreas Wicki knows both worlds very well - 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 on many successful smaller and very complex validation projects in various roles.
Robert Dikti
Quality oriented Junior CSV Consultant with a solid educational background. For the past two years, actively growing and developing, by conducting multiple Pharma IT projects and as a natural progression and continuous development, recently involved in the CSV training as a moderator. Used to act as Veterinary Office Manager and Veterinary Surgeon for 8 years including managing a group of supporting people, maintaining the best quality of services on a daily basis by caring for the health and welfare of animals, always taking human health and quality as priority.
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