CMMI Institute

Capability Counts 2019

30 April & 1 May, 2019

Reston, VA

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Speaker Profile

Tom Klein, Principal and Co-Founder

Two Harbors Consulting

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About

Tom is an expert in business transformation and process improvement and has served as a trusted advisor to business and technology leaders in several countries. Tom has held positions ranging from Product Management to Software Implementation and, for the last six years, directed process improvement engagements at McKesson Corporation.  He is a CMMI Lead Appraiser for Development and Services models, a Certified Scrum Master, and a certified Scaled Agile Framework Program Consultant.  He works with customers as a partner and member of the team, and seamlessly moves from working with brand-new employees to seasoned executives. His goal is to match skills, hard work, and tools to meet the needs of the customer.

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.