CSV Training

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What we offer you

Attend CSV training online or bring training to your organization.

Whether you’re new to validation or a seasoned professional, our computer system validation training and webinars will give you the insight, tools and techniques you need for validation success.

Our computer systems validation experts have developed training courses and webinars to help you apply FDA, ICH, and Eudralex risk-based validation concepts to your projects. Our courses also incorporate industry standards and best practices as found in PIC/S and GAMP.

Courses and Webinars

  • CSV Bootcamp (learn more)

    CSV Boot Camp focuses on building expertise in computer systems validation through dive-in into regulatory and industry standards, and hands-on practice on validation documents and templates.

  • Data Integrity (learn more)

    In this webinar, you will learn how government agencies are becoming more stringent in their requirements and how familiar paper data integrity requirements are being transferred to electronic records and computer systems.

  • CSV Project Management

    We deal with the challenges and the method for implementing computer systems in the regulated environment - what to consider and what is better to avoid!

  • Testing of GxP critical systems

    Learn about testing strategies, types of testing, and required depth of testing in CSV. We look at how risk management is used as a foundation for testing.

  • CSV Introduction workshop (learn more)

    In the CSV introductory workshop, you will learn the basic methodological concepts of validation and receive an overview of the documentation framework.

  • Risk Management (learn more)

    First, you will learn the standard terminology of software validation and risk management. Then we move on to practical approaches for identifying, assessing and classifying the quality risks associated with the software.

  • Operating Phase

    Learn the industry standards for maintaining the validated state of your systems. Focus on change management, a set of procedural instructions for system operation, and periodic testing of systems.

  • Introduction to the regulatory requirements

    We look at similarities and differences in key regulatory requirements. You will gain insight into Annex 11, 21 CFR Part 11 and other regulations.

  • Individual course

    Are you interested in specific aspects of computer systems validation? Would you like to organize your own course date for your team? We would be happy to put together a customized webinar or on-site training.

Contact us now and request your individual consultation

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