PDA Letter
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Points to Consider When Applying QRM

by: Douglas Campbell, InterPro QRA

Knowledge-Driven Impurity Control for NMF Protein Products

by: Qifeng Zhang, PhD, Lonza

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

by: Enrico Barichello

Data Integrity and the Preapproval Inspection

John Godshalk, Biologics Consulting
A Line of Sight Approach for Assessing Aseptic Processing Risk: Part I

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource
Drug Shortage is a "Wicked Problem"

Anders Vinther, PhD, Sanofi Pasteur