PDA Letter
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Validating NGS-Based Assays In-House for Virus Safety Assessment

by: Christoph Bredack, PhD, Genedata

Keep Aseptic Conditions Continuity within Transfer Procedures

by: Lucia Ceresa

An Alternative and Sustainable BET Designed for Patient Safety

by: Parampal Deol

U.S., UK Regulators Share Passion for Quality Culture

Rebecca Stauffer, PDA
PDA’s 4th Metrics Conference

Stephanie Gaulding, DPS Engineering
PQRI Establishes Thresholds for L&E Identification

Walter Morris, PDA
Knowledge is Power

Rafik H. Bishara, PhD, Eli Lilly and Company (retired) and Erik van Asselt, PhD, MSD
Perspectives on Packaging

Rebecca Stauffer, PDA
Industry Experts: Quality Requires Proactive Approach

Rebecca Stauffer, PDA
The Future of Glass in Parenteral Packaging

Robert A. Schaut, PhD, and W. Porter Weeks, Corning Incorporated
New Guidance for Visual Inspection Available

Roy Cherris, Bridge Associates International
Gowning Requirement for Blow-Fill-Seal Technology

Rebecca Stauffer, PDA
MAbs Require Ongoing Dialogue

Ursula Busse, PhD, Novartis, and Steffen Gross, Paul-Ehrlich-Institut
Prefilled Syringes Bring Patient to the Forefront

Mathias Romacker, Pfizer, and Hanns-Christian Mahler, Lonza

Microbiologists Put Under the Microscope

Kathleen Souza, MilliporeSigma
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, Matthias Scheu, METALL+PLASTIC, 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, bigfinite
Buddy Up in Berlin with New PDA Pals

Rebecca Stauffer, PDA
Cost of Quality Still a Factor

Rebecca Stauffer, PDA
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
Japan Chapter Marks 25 Years at Annual Event

PDA Japan Chapter Annual Meeting Committee
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
When a Routine Trip Becomes a 1980s Comedy of Errors

Walter Morris, PDA
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
When Data Integrity Takes Front and Center Stage

Doug Chambers, MilliporeSigma
Three Questions for MHRA’s David Churchward

Rebecca Stauffer, PDA
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