CMC Workshop: From Drug Development to Global Supply to Patients

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Session 10A: Shipments Monitoring and Temperature Control

Session Chair(s)

Kenneth Waterman, PhD

President

Freethink Technologies, Inc., United States

While storage and shipping conditions are qualified based on stability studies, invariably in an increasingly dynamic world market, materials will experience excursions. The responsible company needs to justify the acceptability (or make a decision to discard) of any such drug products. This session will discuss the scientific and regulatory basis for determining the appropriate course of action.

Speaker(s)

Storage Temperature × Humidity Design Space And Logistics Excursions

William R. Porter, PhD

Peak Process Performance Partners, United States

Principal Scientist

Dealing With Temperature Excursions During Shipment And Storage

Manuel Zahn, DrSc, PhD

3R Pharma Consulting GmbH, Germany

Managing Director

Use Of Stability Modeling As Part Of Qbd To Determine The Impact Of Excursions On Drug Substances And Drug Products

Kenneth Waterman, PhD

Freethink Technologies, Inc., United States

President

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CMC Workshop: From Drug Development to Global Supply to Patients

Session 10A: Shipments Monitoring and Temperature Control

Session Chair(s)

Kenneth Waterman, PhD

Speaker(s)

Storage Temperature × Humidity Design Space And Logistics Excursions

Dealing With Temperature Excursions During Shipment And Storage

Use Of Stability Modeling As Part Of Qbd To Determine The Impact Of Excursions On Drug Substances And Drug Products

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