Risk and Change

Concurrent Session

M27 - Back From the Brink

Monday, April 30
3:00 PM - 4:00 PM
Location: WSCC 204

Level: Basic

Division: Customer-Supplier Division

Change is hard! But when you are on the brink of consent decree you have no choice but to implement a robust quality management system! There is no turning back. You have to burn the ships you arrived on and create a new foundation for a new beginning. To implement a successful holistic change, you need oversight of the whole process and a culture of accountability and quality that embraces and accepts the change, making it sustainable. We all know regulations must be met regardless of industry or how prescriptive they may be. This session will provide you with examples of how one company's systems went from barely there to robust; how the oversight of the entire quality system change ensured that each system was integrated into their input and output systems; and how this company was able to demonstrate that it was in complete control of its processes.

Learning Objectives:

Karen Griffin


Quality Compliance Manager, Global Complaint Management
ICU Medical
Antioch, Illinois

Quality Compliance Manager, Global Complaint Management, ICU Medical, formerly Hospira, a Pfizer Company, since January 2011, where her responsibility is to manage compliance to complaint handling activities for both medical devices and pharmaceutical operations. She holds a CMQ/OE certification. Karen has over 15 years of quality compliance experience, managing compliance to CAPA, Change Control, Field Actions, Training, Field Investigations and Regulatory Inspection activities.


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Edward Cook


Director, Supplier Quality Management
ICU Medical
Chicago, Illinois

 Director, Supplier Quality Management, ICU Medical, formerly Hospira, a Pfizer Company, since January 2013, where his responsibility is to manage global SQ program for both medical devices and pharmaceutical operations. He holds these certifications: ASQ-Six Sigma BB, CMQ/OE, CQE, CQA, Exemplar Global Principal QMS Auditor. Ed also helped to develop the new ASQ-CSQP certification, and is an Instructor for the Preparation Course. With over 20 years of manufacturing quality experience, he has served in various roles in and out of the medical field, including Plant QA Head for Husqvarna Outdoor Products; Head of QA/RA for Facet Technologies and Director of Quality, Molding Operations for Avail Medical Products as well as QA Manager roles at several other companies


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Scott A. Laman

ASQ Fellow

Sr. Manager, Quality Engineering and Risk Management
Reading, Pennsylvania

Scott A. Laman has 25 years of experience in applying quality principles to research; process and product development; quality and reliability engineering; and risk management in the chemical, bulk plastics manufacturing, and medical industries. He is currently senior manager, quality engineering and risk management at Teleflex, Inc. in Reading, PA. Laman earned bachelor of science and master of science degrees in chemical engineering from Syracuse University. He is an ASQ Fellow, past chair of the certification board, and present chair of the Professional Ethics and Qualifications Committee. Laman is an ASQ Certified Quality Engineer (CQE), Reliability Engineer (CRE), Manager of Quality/Organizational Excellence (CMQ/OE), Six Sigma Black Belt (CSSBB), Quality Auditor (CQA), and Biomedical Auditor (CBA).


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M27 - Back From the Brink


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