PDA Letter
Quality Metrics to Impact Different Pharma Sectors

Rebecca Stauffer, PDA

Leveraging Video to Improve Operations

Colleen Walson-Billin, Amgen

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

GMP Oversight of Medicines Manufacturers in the European Union

Riccardo Luigetti, EMA, Emer Cooke, EMA, Brendan Cuddy, EMA, Sebastien Goux, European Commission, and Ian Rees, MHRA

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

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

PDA Program to Address Post-Approval Hurdles

PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force

Four Steps to Conducting a Successful Data Integrity Audit

Crystal Mersh, Quality Executive Partners

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