Life Sciences Accelerated

5: Regulated Workloads in the Public Cloud w/ Vishal Sharma and John Petrakis

On this episode of Life Sciences Accelerated, we invited USDM’s Vishal Sharma [https://www.linkedin.com/in/vishal-sharma-6b434113], VP of Digital Transformation, and John Petrakis [https://www.linkedin.com/in/john-m-petrakis/], VP of Cloud Assurance, to talk about how to manage your regulated GxP workloads in the public cloud. John holds 30 years of global industry experience in business transformation, delivering solutions that address regulatory and quality pressures. He’s led all aspects of strategy development, delivering value for pharma, biotech, medical device, and healthcare companies. Vishal has spent more than 20 years in life sciences, developing core competencies using emerging technologies to help customers fast-track their digital transformation and achieve high-impact business outcomes. What we discussed: * The transition from on-premises technologies to the cloud * How cloud computing evolved from traditional IT to new service models * How regulatory requirements have affected the adoption of newer technologies * New things to do with tech like Microsoft Azure, Google Cloud Platform, and AWS * Advice for life science companies considering moving to the public cloud Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts [https://podcasts.apple.com/us/podcast/life-sciences-accelerated/id1521958310], Spotify [https://open.spotify.com/show/3Ylou4sLgTT1YE8HgIfxWZ], or our website [http://www.usdm.com].

4: GxP Content and Document Management Best Practices w/ Vishal Sharma and Manu Vohra

On this episode of Life Sciences Accelerated, we invited Vishal Sharma [https://www.linkedin.com/in/vishal-sharma-6b434113/], the VP of Digital Transformation at USDM, and Manu Vohra [https://www.linkedin.com/in/manu-vohra-11b9ab1/], the Managing Director of Life Sciences at Box, to talk about content and document management in life sciences. Vishal develops core competencies using emerging technologies to help customers fast-track their digital transformation and achieve high-impact business outcomes. Manu deploys content management solutions for life sciences while running operations within several IT functions supporting drug discovery to commercialization. What we discussed: * Why content management is different for regulated companies * Evolution of content management in the life sciences * How to manage cloud compliance * How Unify Cloud Compliance addresses life science business needs Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website [https://www.usdm.com/].

3: Global UDI and EU MDR Requirements w/ Jay Crowley

Jay spent 26 years at the FDA, and he developed the requirements for the FDA's UDI system and was one of the authors of the US UDI rule. Jay explains what the delay of enforcement for some class I devices in the US means. Jay Crowley [https://www.linkedin.com/in/jay-crowley-478a7312/], VP and UDI Practice Lead at USDM Life Science [https://www.usdm.com/Home] What we talked about: * What are the details of the new UDI and MDR requirements * Determining your organization's requirements * Strategies to implement adapted practices Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website [https://www.usdm.com/].

2: Cloud-Based Systems in Life Sciences w/ David Blewitt

He's an accomplished life sciences, regulatory and ISDN compliance professional. With more than 25 years of experience in the pharmaceutical medical device, biotech and blood management industries, specifically in the fields of computer systems, validation, risk management, and quality assurance, software development, product, life cycle management, and compliance roadmap development. David Blewitt, [https://www.linkedin.com/in/david-blewitt-73197a/] Vice President of Cloud Compliance, USDM Life Sciences [https://www.usdm.com/Home] What we talked about: * Cloud usage in Life Sciences * New applications for usage * Adapting to conducting business in a COVID 19 environment Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website [https://www.usdm.com/].

1: Adapting Computer System Validation to Accommodate Evolving FDA Guidance w/ Diane Gleinser and Sandy Hedberg

As the Life Sciences adapt to manufacturing amidst Covid-19, the FDA is also updating guidelines for computer system validation. So, what does this mean for your organization? Diane Gleinser [https://www.linkedin.com/in/diane-gleinser-4244bb1/] and Sandy Hedberg [https://www.linkedin.com/in/sandyhedberg/] discuss the intricacies of the new guidance, and how you will need to adapt when it comes to showing evidence that the computer systems you're using comply with the predicate rules. Diane has an impressive background in the Life Sciences, and brings her experience, knowledge, and her certification in medical device and pharmaceutical law to USDM and the industry as a whole. Diane Gleisner [https://www.linkedin.com/in/diane-gleinser-4244bb1/] , VP Life Science Services and Solutions Sandy Hedberg [https://www.linkedin.com/in/sandyhedberg/] QA/RA Manager, Cloud Assurance at USDM Life Sciences USDM Life Sciences [https://www.usdm.com/Home] What we talked about: * Changes coming to Computer System Validation * The FDA’s urging company’s to utilize automation in their manufacturing process * CSA approach vs CSV  approach Find this interview and many more by subscribing to Life Sciences Accelerated, on Apple Podcasts, on Spotify, or on our website [https://www.usdm.com/].