Managing Change
Concurrent Session
Cherron Blakely, MBA, CQA, CQIA, LSSGB
Associate Director, Quality Management
Office of Product Evaluation and Quality (OPEQ),
Center for Devices and Radiological Health,
Food and Drug Administration
Silver Spring, Maryland
Patrice Griffith, MBA, CMQ/OE, CQA, MT(ASCP)
Director, Quality, Safety and Outcomes Education
University of Texas Southwestern Medical Center
Flower Mound, Texas
Level: Intermediate
The Center for Devices and Radiological Health (CDRH) is building and implementing a new approach to how business is conducted and structured. The total product life cycle (TPLC) is a holistic approach inclusive of all the steps and processes that lead to the design, production, use, and impact of safe, effective, and high-quality medical devices. While undertaking a massive reorganization, how does this regulatory organization maintain the tenacity to adapt to change while protecting the U.S. public? In this session, we will discuss how leaders of the organization embraced the opportunity to transform while engaging actively in an adaptive change cycle that included high collaboration, a communication strategy, stakeholder agreement, and a strong desire for effective and efficient outcomes to successfully restructure.