PDA Letter
Home / PDA Letter / Quality and Regulatory

Quality and Regulatory

Regulators, USP Taking a Close Look at Visual Inspection

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, rap.ID Particle Systems GmbH

A QUICK Guide To Selecting a CMO

Brittany Cloud, Eurofins Lancaster Laboratories, Inc.

Quality Metrics to Impact Different Pharma Sectors

Rebecca Stauffer, PDA

Storm Surrounds Clinical Trial Data in China

Yingying Liu, ECURAC, and Siegfried Schmitt, PAREXEL

Annex 1 Showcases the Need for Clear Guidance

Geert Vandenbossche, Novartis; Marc Besson, Sanofi; Gabriele Gori, GSK Vaccines; Jette Christensen, Novo Nordisk; Gerry Morris, Eli Lilly and Company

Four Steps to Conducting a Successful Data Integrity Audit

Crystal Mersh, Quality Executive Partners

Data Integrity and the Preapproval Inspection

John Godshalk, Biologics Consulting

Drug Shortage is a "Wicked Problem"

Anders Vinther, PhD, Sanofi Pasteur