September 26, 2018   
Gillette Stadium

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A Proven Approach to Increasing Compliance While Increasing Efficiency: A Win/Win for Everyone

4:30 PM – 5:30 PM  

This presentation provides a systematic approach and proven strategies for the development and implementation of quality by design programs that employ “right first time” strategies. While focusing on Quality Risk Management systems (QRM) this presentation demonstrates how to align critical processes and programs that meet today’s stringent business needs and regulatory expectations. Unlike typical leveraging strategies that ignore the complexities associated with engineering and quality approvals we demonstrate a very simple easy to follow approach with elimination of typical protocols and truly focuses on right first time. The strategy outlined here also aligns facilities, utilities and process equipment design structure with a CQV program that works with existing operations. This strategy has been tested, proven and is a total game changer.

Speaker: Michael Bogan | President | ICQ Consultants

Mr. Bogan has been working in the life sciences industry for over twenty five years supporting operating companies, facility expansions and green field projects. As a veteran of the armed forces Mr. Bogan understands the importance of discipline and focus that an organization requires to meet their objectives. His leadership and vision have been recognized by many in the industry as being both creative and inspiring. Michael was a co-author for “Risk Management Applications in Pharmaceutical and Bio pharmaceutical Manufacturing:; chapter 7: Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment.