Webinar: Risk-Based Testing in CSA

Webinar

Risk-Based Testing in CSA

Join us in exploring the transformative impact of Risk-Based Testing in CSA (Computer Software Assurance) on software quality and compliance. In this webinar, we’ll examine how adopting CSA principles shifts the focus from documentation-heavy practices to more efficient, agile approaches, enhancing the reliability and integrity of computerized systems.

Discover the advantages of risk-based testing, prioritizing critical focus areas, reducing unnecessary efforts, and streamlining assurance activities. We’ll discuss key topics, including the classification of computerized systems, testing rigor, and the use of innovative testing methods, such as unscripted testing, to achieve better outcomes with fewer resources.

Learn how CSA’s methodologies enable organizations to balance risk, quality, and compliance effectively. Gain insights from our experts on optimizing your software assurance processes to meet regulatory requirements while improving efficiency and overall system performance.

Discover key webinar insights

  • 01

    CSV vs. CSA: Understanding the Shift

    Explore the evolution from traditional Computer System Validation (CSV) to modern Computer Software Assurance (CSA) and what it means for compliance and efficiency.

  • 02

    Risk-Based Approach and Assurance Activities

    Learn how risk assessments shape assurance activities, focusing on what truly matters for system reliability and quality.

  • 03

    Ensuring Testing Rigor

    Delve into strategies for maintaining appropriate testing rigor tailored to the risk and criticality of computerized systems.

  • 04

    Implementing Risk-Based Testing

    Discover the principles of risk-based testing and how they optimize resources while improving compliance and quality.

  • 05

    Classification of Computerized Systems

    Understand how system classification drives the scope of assurance activities and testing requirements.

  • 06

    Exploring Different Types of Testing

    Gain insights into various testing methods, including unscripted testing, and their role in modern software assurance frameworks.

Piotr Nowicki
Validation Lead at Billennium

Piotr has over 7 years of experience in validation within the pharmaceutical industry and GxP environments. His expertise spans Computerized Systems Validation, packaging process validation, and Quality Assurance. He specializes in implementing and maintaining computerized systems aligned with CSV and CSA frameworks, helping organizations ensure regulatory compliance, boost efficiency and enhance system quality.

Outside work, Piotr is passionate about adventure – exploring new destinations or hitting the open road on his motorcycle.

Jeff Ramos
Solution Engineer at ValGenesis

He has spent over 13 years as a Quality Specialist and Software Validation Engineer. He has worked across sectors, from bio-pharmaceuticals and start-ups to global companies, refining his software validation and quality assurance expertise.

Beyond his professional life in IT, he is deeply involved in the San Francisco Bay Area Theatre Community as a performer, collaborator, and creator. He also serves as the Head Coach and Lead Instructor at a fitness studio, where he helps individuals improve their physical and mental well-being.

In his spare time, he enjoys editing music videos, participating in Spartan Obstacle Races, and traveling the world. Passionate about continuous learning and improvement, he is excited to share practical insights into CSA and paperless validation with you in this webinar.