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Computer Software Assurance for FDA-Regulated Industries

  August 28, 2023  
Xtalks, online
2023 -9-29

Many Food and Drug Administration (FDA) regulated manufacturers may encounter confusion and uncertainty when it comes to implementing computer software assurance (CSA) effectively. This webinar is specifically designed to tackle these pain points head-on, providing the attendees with the clarity they need to succeed.
Throughout this engaging session, industry experts will provide clear explanations of the core distinctions between computer software assurance and computer system validation (CSV). Attendees will be provided with a clear understanding of why and when FDA-regulated manufacturers should utilize computer software assurance for regulatory compliance. In addition, the key goals of computer software assurance and its fundamental concepts will be reviewed including Intended use and risk assessment. Further, the essential principles of computer software assurance to gain insights into how these concepts impact software quality, safety and compliance will be discussed.
Understanding the specific scenarios and circumstances where computer software assurance is most beneficial will allow organizations to make informed decisions when it comes to software validation, ultimately ensuring compliance. Attendees will also learn how to maintain the appropriate records to meet FDA requirements to establish appropriate assurance activities and records.
As the regulatory landscape becomes increasingly complex, staying ahead of the curve is crucial. Join this webinar to embrace the future of software compliance and learn how to navigate regulatory requirements more effectively to elevate a company’s success.
Organized by: Xtalks
Invited Speakers: Kevin Marcial, CSV/CSA Services Manager, Principal Validation Specialist, Performance Validation Hemadri Doma, QA Computer System Validation Engineer III, Tolmar Inc.
Deadline for Abstracts: 2023 -9-29
Registration: Free registration
E-mail: ajuurinen@xtalks.com
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