In this episode, we will hear an exclusive panel discussion CSV Virtual Event "CSA Revolution." This discussion will provide a better understanding of the intent and scope of the FDA’s Computer Software Assurance guidance while highlighting CSA’s relationship to other existing regulations. Key concepts of CSA include the push for critical thinking and risk-based principles as part of the lifecycle strategy in support of data integrity, and how CSA promotes better use of data for the benefit of patient safety and product quality.

The panelists for this discussion:

Senthil Gurumoorthi - Director IT Gilead Sciences

Cisco Vicenty - Program Manager Case for Quality FDA

Ray Murphy - Principal Engineer Corporate Software Quality Boston Scientific

Ken Shitamoto - Senior Director IT Gilead Sciences

Khaled Moussally - EVP Clients & Regulatory Relations Compliance Group Inc.

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