2016 PDA Manufacturing Science Workshop

Hal Baseman

Working Session 2: New Approaches for Incorporating Process Variability to Improve Processes

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Daniel Blackwood

Presentation not authorized for distribution.

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Yanxi Cain, PhD

Working Session 5: The Role of Analytical Testing Capability in Product Lifecycle Management

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Brett Duersch, PhD

P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls & Variability

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Paula Katz

P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls and Variability

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Gerald Leister

P1: Understanding the New Regulatory Inspections Models: Data Integrity and Manufacturing Controls & Variability

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Anil Sawant, PhD

Working Session 4: Preventing Data Integrity Issues

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Susan Schniepp & Anders Vinther, PhD

Fishbowl -What's Holding Us Back from Improving our Processes and Methods - Challenges with Post Approval Changes?

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Anders Vinther, PhD

Working Session 3: Product Lifecycle Management - Facilitating Innovation and Drug Product Availability with Reduced Regulatory Burden

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Glenn Wright

Working Session 1: Understanding Process Variability and Identifying Areas for Process Improvement

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