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Podcast: Voices In Validation
Episode:

Computer Software Assurance and an Evolving Risk-Based Quality Approach
Category: Science & Medicine
Duration: 00:56:34
Publish Date: 2020-09-08 04:01:00
Description:

In this episode, Stacey hosts a panel discussion on computer software assurance. Stacey is joined by industry experts, Raechelle Raimondo, Ken Shitamoto, Pritam Khade, and Senthil Gurumoorthi, to talk about the upcoming guidelines from the FDA on computer software assurance, testing requirements, IT automation, risk, quality culture, and critical thinking mindset in the industry.

 

Raechelle Raimondo - Raechelle has more than 20 years of experience working for large/global corporations, small businesses and start-up companies. A proven history of implementing global systems utilizing a risk based systems lifecycle (SLC) approach and managing teams to support multiple projects, including forecasting and managing budgets. Strengths include leadership, portfolio/program management, delivering results, managing multiple priorities, effecting change, building teams, problem-solving, using interpersonal skills to build effective relationships, and understanding the link between technology & business needs to deliver compliant solutions that optimize processes & efficiencies.

 

Ken Shitamoto - Ken Shitamoto leads the IT quality engineering function at Gilead Sciences, which performs software quality assurance (testing), validation, and infrastructure qualification. He is a multi-disciplined professional with extensive experience in quality engineering, quality management, project management, and software development. He has been in the biopharmaceutical space since 1993 and has worked both on the manufacturer, vendor, and consulting sides of the business. Additionally, he has also performed over 100 GXP computer systems compliance audits globally. He holds a BA Molecular Cell Biology and MS Computer Science and from UC Berkeley and San Jose State University respectively. He is an avid supporter of the American Lung Association, and Ken and his daughter have raised over 130K dollars to fight lung disease.

 

Pritam Khade - Pritam is a Director of Global Quality Compliance at Allergan Inc.

 

Senthil Gurumoorthi – Senthil is a Director of IT Services at Gilead Sciences.

 

Voices in Validation brings you the best in validation and compliance topics. Voices in Validation is brought to you by IVT Network, your expert source for life science regulatory knowledge. For more information on IVT Network, check out their website at http://ivtnetwork.com.
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