PDA Letter
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Happy Holidays from PDA!

by: PDA, Inc.

Points to Consider When Applying QRM

by: Douglas Campbell

Knowledge-Driven Impurity Control for NMF Protein Products

by: Qifeng Zhang, PhD, Lonza

A Line of Sight Approach for Assessing Aseptic Processing Risk: Part II

Hal Baseman, Marsha Hardiman, Walter Henkels and Mike Long, ValSource
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