Risk and Change

Workshop

W11 - Change Management and Control: Lessons From a Consent Decree

Wednesday, May 2
8:00 AM - 10:30 AM
Location: WSCC 4C 1-2

Workshop

Level: Intermediate

The pharmaceutical industry is one of the most regulated industries. In the United States, the Food and Drug Administration (FDA) often uses the consent decree as the ultimate enforcement tool for those who break the rules. A company under consent decree needs to prove, via third party, that it has achieved and can sustain regulatory compliance. Companies under a consent decree must break down and build up their entire quality system. In this session, you will get lessons learned from a consent decree to build a robust pharmaceutical quality system and see how pharmaceutical experience can deepen your understanding of ISO 9001:2015, especially risk-based thinking.

Learning Objectives:

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Jeremiah B. Genest

Manager, Quality Systems
Sanofi
Boston, Massachusetts

Jeremiah Genest has 20 years quality systems experience in the energy and pharmaceutical industry, with over a decade’s experience implementing and running quality systems in the biotech field. For the last four years, he has managed change management at Genzyme’s Allston Landing Facility, which is under an FDA Consent Decree. He is a Certified Manager of Quality/Operation Excellence and Pharmaceutical GMP Professional.

Presentation(s):

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Patrice Griffith

MBA, CMQ/OE, CQA, MT(ASCP)

Director, Quality, Safety and Outcomes Education
University of Texas Southwestern Medical Center
Flower Mound, Texas

Patrice Griffith is the Director, Quality, Safety and Outcomes Education at University of Texas Southwestern Medical Center where she is responsible for Quality Improvement activities and education for the organization’s Health Systems, Academic Affairs and Business Affairs.
Previously, she worked for Abbott Laboratories as the Quality Systems Manager for a medical laboratory manufacturing facility and as a laboratory mentor in Tanzania.
Patrice received her MBA in Quality and Industrial Management at the University of Dallas, a B.S. in Medical Technology at Michigan State University and an A.S. in Biomedical Electronics.
She is currently serves as a judge and on the training faculty for the Quality Texas Foundation and serves as an alumni examiner for the Malcolm Baldrige Nation Quality Award.
Patrice is a registered Medical Technologist (MT ASCP) and hold certifications (ASQ) as a Quality Auditor and Manager of Quality and Organizational Excellence.

Presentation(s):

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