PDA Letter
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Q&A on the Revised PDA Technical Report No. 22

by: Subrata Chakraborty, GxPfont Consulting Group , Vanessa Figueroa, VVF Science , and Marcia Baroni, Emergent BioSolutions Inc

Microbial Ingress No Longer an Effective CCI Test Method

by: Oliver Stauffer and Tyler Harris

Understanding Japan Quality

by: Antonio Burazer

Human Element Key to Digital Transformation

Rebecca Stauffer, PDA
A QUICK Guide To Selecting a CMO

Brittany Cloud, Eurofins Lancaster Laboratories, Inc.
IG Meetings to Address Complexity of New Products

Lee Leichter, P/L Biomedical
How to Get Your ATMP From the Lab to the Market

By: Andy Fry, Team Consulting

Viral Safety Approaches for Advanced Therapy Medicinal Products

Thomas R. Kreil, PhD, Global Pathogen Safety, Shire
WHO Should Align with ICH on PACs

Rebecca Stauffer, PDA
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