CSV: Digital Transformation Initiative

In this episode, we will hear an exclusive conversation from the recent CSV Virtual Event, "Digital Transformation Initiative" This discussion was moderated by Daniel Matlis and features Sam Cheemokati, Paul Hurlocker, and Ron Schardong. 

The discussion will be focused on exploring organization-wide digital transformation initiatives. The panel will share their firsthand experiences of point solutions to platforms transitions. And, the best practices when shifting to cloud computing and the cloud-first approach.

About the panel:

Daniel Matlis

Daniel R. Matlis is the Founder and President of Axendia – a trusted advisor to Life-Science and Healthcare executives on business, technology, and regulatory issues.

Dan’s career in the industry spans over 20-years and has included projects in research & development, manufacturing, regulatory compliance, business development and information technology.

Prior to founding Axendia, Dan was General Manager & VP at Stelex (now a GE company) – a leading consultancy to life-science companies.

He started his professional career at Ethicon, Inc., a Johnson & Johnson Company.

Sam Cheemakoti

Sam is the GMP Head at Beiersdorf for the Coppertone Division overseeing GMP compliance of its computer and automated systems. Sam has held positions of increasing responsibility at various Pharmaceutical companies such as Bayer, Merck, and Schering Plough in the areas of Computer Systems Validation, IT Compliance, and Quality Assurance. As a Quality leader with 20+ years in the industry with a demonstrated ability to produce and deploy Part 11 and Data Integrity remediation programs, validation programs, quality systems, strategic initiatives for Quality and Compliance especially under conditions of the consent decree, acquisitions, and divestitures has lent him unique perspectives as a change ambassador and thought leader. Sam earned his MS in Industrial Engineering from Louisiana Tech University and his Project Management credentials from Villanova University. He more recently completed a course on Digital Transformation: Leading People, Data and Technology from the University of Berkeley under their Executive Education Program in order to gain synergies between the two journeys of Digital Transformation and Computer Software Assurance for Quality. 

Paul Hurlocker

Paul is the CTO at Spring Oaks Capital, a technology-driven financial services company whose mission is to reinvent the debt recovery industry by providing a customer-centered user experience and streamlined operations powered by data and machine learning. Paul previously served as the Senior Director and Vice President of the Center for Machine Learning for Capital One. Paul founded Notch, Co and served as the CEO before selling the company to Capital One.

Ron Schardong

Ron is privileged to lead Johnson & Johnson’s Technology Quality group responsible for computerized systems validation of business applications in the Medical Devices, Consumer, and Pharmaceutical segments worldwide. The applications include ERP, Warehouse Management, Manufacturing, Laboratory, Quality Systems, Clinical, R&D, Enterprise Tools, Services, and Infrastructure. He has over 25 years of experience in quality engineering, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of FICSA Group (FDA + Industry Computer Assurance Group).

 
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