CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Becky Fitzgerald, Principal and Co-Founder

Two Harbors Consulting

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About

Becky has extensive experience in healthcare corporate, consulting, and academic environments.  In the 90s Becky launched and ran the largest U.S. independent dermatopathology lab forging the first partnership with Federal Express and defining specimen handling standards.  In the 2000s, Becky designed and launched the first anatomic pathology system to address automated positive patient identification for all histology, molecular, and cytology specimens, slides and whole slide images, reducing specimen swap rates to zero. Becky is a Certified CMMI Lead Appraiser, Instructor, and Enterprise Data Management Expert with expertise in laboratory regulations, ambulatory, hospital, laboratory, and imaging workflows, and medical device development. Becky has consulted with organizations globally in technology forecasting and adoption; workflows, value streams and operations; and business performance evolution.

SPEAKER PRESENTATION

Panel Discussion: CMMI V2.0 Early Adopters

Conference Track: Panel Discussion

This presentation will include a panel sharing customer experiences from adopting CMMI V2.0.

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.