Quality and Computer Software Assurance
Voices In Validation
English - October 22, 2019 05:00 - 32 minutes - 29.6 MB - ★★★★★ - 8 ratingsChemistry Science Homepage Download Apple Podcasts Google Podcasts Overcast Castro Pocket Casts RSS feed
On today’s episode, Stacey Bruzzese welcomes Steve Thompson, Director Computer Quality Assurance for Science 37.
Stacey and Steve talk about a variety of topics:
Why is the FDA’s Case for Quality which launched in 2011 just now being implemented on a more widespread level?
What challenges are posed by implementation?
Steve walks through the core components of the Case for Quality
Although it will roll out as a voluntary pilot program, what does Steve see as the progression over the coming months and years?
Mr. Thompson has over 20 years’ experience in life science working in Quality Assurance and Information Technology functions that span GxP regulations, both domestic and international. Steve has worked for start-ups and large multinational companies that includes biotechnology, pharmaceutical, medical device, and cloud-based Software-as-a-Service (SaaS) solution providers. He is a published author, was certified as a PDA Systems Auditor in 2003, and received a Bachelor of Science, Computer Information Systems, in 1986.
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.