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Session Chair(s)
Sarah Powell, RAC
President
Powell Regulatory Services, United States
Learning Objective : 1. Recognize the challenges facing the life sciences industry specific to Regulatory Operations 2. Identify the main components of Quality by Design (QBD) 3. Apply core QBD principles and approaches to their day-to-day work in Regulatory Operations
Speaker(s)
Quality by Design and the Strategic Transformation of Regulatory Operations
Joe Shepley, PhD, MA
Ankura, United States
Managing Director
Speaker
Christopher P Hanna, PhD, PMP
Kattner-Thalmann Partners, United States
Principal
The Future Regulatory Operations Organization
Elizabeth M Turek
Johnson & Johnson, United States
Head, Knowledge Management