PDA Letter
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Effective AI Deployment in Drug Manufacturing

by: Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

Engineering Excellence in Container Closure Integrity Testing

by: Oliver Stauffer

The mRNA Revolution

by: Amisha Patel

How to Use QbD to Select Packaging Components

Nrupa Patel, Teligent Pharma Inc., and Sandip Patel, Navinta LLC
Putting the Pieces Together

Wendy Saffell-Clemmer, Baxter Healthcare

Creating a Global Incentive for Pharma

Anders Vinther, Sanofi Pasteur; Emma Ramnarine, Genentech; co-chairs PDA Post Approval Change: Innovation for Availability of Medicines (PAC iAM) Task Force
Lower the H202 Concentrations in Your Isolator with One Easy Upgrade

Stefan Kleinmann, PhD, METALL + PLASTIC GmbH , Matthias Scheu, METALL + PLASTIC GmbH , Roland Schuhwerk, Cilag AG , and Volker Baur, Cilag AG

Hear From Industry, FDA Leaders on the Issues of the Day

Susan Schniepp, Regulatory Compliance Associates, and Steven Mendivil, Amgen
Pharma Has its Head in the Cloud

Toni Manzano, PhD, Aizon

A Case Study in Aseptic Gas Plasma Decontamination

Egmont Semmler, Groninger & Co.

Regulators, USP Taking a Close Look at Visual Inspection

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

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