CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Mike Ingles, Business Excellence and PMO Manager

Edwards Lifesciences’ Draper, Utah Plant

About

Michael Ingles has extensive experience in the Medical Device environment. He currently serves as Business Excellence and PMO Manager for Edwards Lifesciences’ Draper, Utah Plant. Previously, Michael was working in Finance for over 10 years at Edwards when he was asked to lead a culture change project. He began by teaching Speed of Trust and DISC to all employees at his plant, and helped create an internal assessment (Operational Maturity Index) to help drive improvement at all the Edwards Lifesciences Plants around the world. This assessment is now conducted yearly within each plant. In 2018, Edwards Lifesciences was recognized as one of the best places to work by Utah Business Magazine, which is something Michael takes immense pride in. 
 

SPEAKER PRESENTATION

Panel: How to be an Appraiser in MDDAP

Conference Track: Improving Capability in the Medical Device Industry

The FDA’s collaborative pilot program intends to simplify regulatory requirements for medical device makers who are committed to quality manufacturing practices. The pilot program leverages CMMI V2.0 to assess medical device manufacturers against industry best practices and offer improvement opportunities. Find out more about the tailored application of CMMI V2.0 and what it takes to get involved.