CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Stephanie Fossat-Dominguez, VP of Operations

CeloNova BioSciences

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About

Stephanie Fossat-Dominguez is currently the VP of Operations at CeloNova BioSciences in Carlsbad, CA.
 
CeloNova BioSciences, Inc. is an innovative global medical device leader transforming the treatment of cardiovascular disease and promoting positive outcomes in patients around the world.
 
Stephanie is responsible for the overall effectiveness and integrity of CeloNova’s operations. Her team manages all aspects of manufacturing and quality for its latest product COBRA PzF. She actively supported the Due Diligence that resulted in the successful acquisition of one of CeloNova’s products. She has worked for 11 years in various quality positions in the medical device industry in both large and small company environments. She thrives on finding a balance between regulations and activities that will benefit both patients and users. Before joining the medical device field, Stephanie gained broad experience in the semiconductor industry where she worked for 11 years for International Rectifier (now Infineon, Vishay). There she made impactful contributions in manufacturing line transfers, as well as production, process and supplier optimizations, in the US, Mexico and Italy.
 
She holds a MS in Engineering in Material Science from Institute National des Science Appliqués (INSA) Toulouse, France and is ASQ CQE certified since 2007.
 

SPEAKER PRESENTATION

Panel Discussion- CMMI V2.0 – Appraisal Experiences

Conference Track: Panel Discussion

This presentation will include a panel sharing CMMI V2.0 appraisal experiences.

Panel: Building Capability in the Medical Device Industry

Conference Track: Improving Capability in the Medical Device Industry

Hear first-hand accounts of adopting CMMI V2.0 from participants of the collaborative FDA pilot program that endeavors to build a culture of quality across the medical device ecosystem. Enrolled device-makers receive a tailored evaluation appraisal to understand their capabilities against industry best practices and identify improvement opportunities. Panelists will speak to individual stories, broader themes, and answer questions.