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Session 4: Risk Management and The Transfer to Operations: Including a Digital Health Perspective
Session Chair(s)
Karthik Balasubramanian, PhD, MS
VIce President, CMC & Technical Operations
Verrica Pharmaceuticals, United States
This session will cover how to effectively handle risk management when transferring a combination product into manufacturing operations. The session will not only cover general principles of risk management and transfer, but also delve into a case study for a digitally connected drug-device combination product. In addition, the session will cover effective operational transfer of risk management for both software and a combination product.
Learning Objective : - Identify key principles of risk management during transfer
- Recognize important watch-outs for operational transfer of a risk file
- Describe integration of internal and external manufacture into risk management
Speaker(s)
Speaker
Enric Calderon, MS
Teva Pharmaceuticals, United States
Associate Director Combination Products and Devices R&D
Speaker
Eric Chan, MS
Director of Product Management, Digital Health, United States
Teva Pharmaceuticals
Speaker
Robert Labaczewski
Bracco Diagnostics, United States
Director- Device Quality