Organization of Regulatory and Clinical Associates
P.O. Box 3490
Redmond, WA 98073
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WEBINAR - Utilizing a Risk Based Approach to Optimize Regulatory Strategies for Innovative Products
TOPIC: Utilizing a Risk Based Approach to Optimize Regulatory Strategies for Innovative Products
TOPIC DESCRIPTION: This will be a case-based discussion looking at the risk analysis components of bringing an innovative product through regulatory strategy. We will consider pre and post market expectations through a few examples such as a software solution and a novel hardware device. We will consider the De Novo or PMA routes for market acceptance.
SPEAKER: Naveen Agarwal, Ph.D.
Creative Analytics Solutions, LLC
SPEAKER BIOGRAPHY: Dr. Naveen Agarwal has 20+ years of diverse industry experience in leadership roles ranging from R&D to Product Quality and Business Analytics. He holds a Ph.D. in Polymer Science & Engineering from University of Massachusetts, Amherst. He is an ASQ certified Quality Engineer, Manager of Quality and Operational Excellence and a certified Project Management Professional. In his consulting practice, he works on strategic projects in Risk Management, Design Control, Post-Market Surveillance and Quality Culture in the Medical Device Industry.
In his spare time, he enjoys distance running, community work and spending time with family.
WHO: Clinical, regulatory, quality, manufacturing and legal
Attendance at this meeting may be applied as 1.5 points towards RAC re-certification
All attendees must be registered. Access to education content is a benefit of membership or guest attendance. The link to the webinar is intended for the registered person ONLY and any access/distribution of materials beyond the individual registrant is strictly prohibited. Viewing rights are not transferable and cannot be combined by multiple parties without express permission. Thank you for your understanding.
This webinar will be recorded.
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