PDA Letter
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Challenges in Sterilizing Indirect Product-Contact Surfaces

by: Cecilia Pierobon, STERIS

From Lab to Market

by: Tejesh Marsale

Uncovering the Symbiotic Link Between KM and AI

by: Marty Lipa, Anne Greene, Paige Kane, Michele Simone, and Toni Manzano

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