Computer Software Assurance for FDA-Regulated Industries

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.

Speakers

Kevin Marcial, CSV/CSA Services Manager, Principal Validation Specialist, Performance Validation

Kevin Marcial has over 17 years of experience in validating FDA-regulated projects for pharmaceutical, medical device and research organizations. His experience includes successful validations for a wide range of system types, including ERP, MES, LIMS, lab instrumentation, document management and electronic QMS. Throughout his career, he has developed a deep understanding of general FDA system compliance, including system risk assessment, software vendor evaluation, 21 CFR Part 11 compliance and data integrity assessment. Kevin is also a CSV/CSA keynote speaker who has presented at numerous pharma and medical device industry events.

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Hemadri Doma, QA Computer System Validation Engineer III, Tolmar Inc.

Hemadri Doma is an industry expert with over nine years of experience in computer system validation (CSV) within the pharmaceutical and medical device sector. He has worked with companies such as Gilead, Allergan and Medtronic, holding various roles such as CSV Engineer, IT Validation Engineer, Equipment Engineer and Automation Systems Administrator. Hemadri is well-versed in computer systems validation, computer software assurance, data integrity, process automation, equipment validation and facilities validation. Currently, Hemadri is a QA Computer System Validation Engineer III and Site CSV/CSA SME at Tolmar Inc.

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