Critical Thinking, Assessing Risk, and Patient Safety – Setting the Record Straight on CSA
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Description
We have entered an era of accelerated digitalization in Life Sciences. Innovation has been thrust upon many across industries as a need to work remotely, automating tasks and virtual collaborations were necessary during the pandemic. Maintaining this accelerated pace, fully embracing the adoption of technology and automation, is the next hurdle we face. Will CSA get us there? Here to demystify the CSA shift is Ron Schardong, Sr. Director of Quality at J&J.   About Our Guest: Ron Schardong is privileged to lead Johnson & Johnson’s Technology Quality group responsible for Quality Management System for IT, Software as Medical Device, Externally Facing Digital Assets, external advocacy, quality strategies for emerging technologies, and digital surgery platforms across Medical Devices, Consumer and Pharmaceutical segments worldwide. He has over 25 years of experience in quality engineering, computer software validation, supplier quality, quality auditing, quality management, regulatory compliance, and regulatory affairs. Ron is one of the original members of the FICSA Group (FDA + Industry Computer Assurance Group).   Disclaimer: This presentation is intended for educational purposes only and does not replace independent professional judgment. Statements of fact and opinions expressed are those of the participant individually and, unless expressly stated to the contrary, are not the opinion or position of Johnson & Johnson or its affiliates.   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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