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This session will provide state-of-the-art examples and tools for process control and quality risk management. Presentations will cover topics from Continuous Process Verification (CPV) to strategies for creating a holistic understanding of the quality system; and Annex 1 approaches to risk activities, including risk assessment tools that will enable the contamination strategy goals.
Session Leader(s):
Christa
B. Myers,
Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader,
CRB
Speaker(s):
Tim
Dreckmann,
PhD,
End-to-End Continuous Process Verification Manager,
F. Hoffmann-La Roche Ltd.