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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
Managing Director, Ankura, United States
Speaker
Christopher P Hanna, PhD, PMP
Principal, Kattner-Thalmann Partners, United States
The Future Regulatory Operations Organization
Elizabeth M Turek
Head, Knowledge Management, Johnson & Johnson, United States