PDA Letter

Features | Sterile Processing

Who Picked That Supplier?

Dr. Jane Zhang, ETCH Sourcing , Nazifa Rahman, ETCH Sourcing , and Anna Schniepp, ETCH Sourcing

Supply Challenges and Future Technologies in 2025

Deirdre Tobin and Connie Leech

Sponsored by Particle Measuring Systems

Normalized Data in Microbial Continuous Monitoring

Rosa Laronga, Giulia Paternò, and Serena Steidl

Previously Featured Articles

Aseptic Processing & Sterilization

Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem

Get Ecstatic for Aseptic

David Keen

What is the Best Way to Control Contamination on the Hands?

PDA Staff Author: David Jaworski, MBA

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon

Five Important Insights from the PDA Europe Annex 1 Event

Patrick Nieuwenhuizen

GMP Annex 1 Implementation

Andrea Salmaso

More Articles

Biopharmaceuticals & Biotechnology

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker

Disruptive Innovations Shaping the GLP-1 Landscape

Anya Hillery, PhD, Freelance Medical Writer

The Need for Manufacturing Speed

Michael Anyadiegwu, PhD Renske Hesselink, PhD Ingrid Kromann

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello

Microbial Ingress No Longer an Effective CCI Test Method

Oliver Stauffer Tyler Harris

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

More Articles

Manufacturing Science

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

From Lab to Market

Tejesh Marsale

GMP Annex 1 Implementation

Andrea Salmaso

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure

Enrico Barichello

The High Cost of Cheap Drugs

Martin VanTrieste

More Articles

People

Community News Quarterly | July 2025

PDA

Managing Talent Risk in Emerging Cell and Gene Therapy Biotechs

Tamer Helmy, PhD

Beyond the Vial

Philippe Lauwers Coralie Richard

PDA Spotlight: The Power of Networking and Innovating

PDA

Bridging Academia and Industry

Renee Morley, MBA

PDA Puerto Rico Chapter Reignites

PDA Puerto Rico Chapter

More Articles

Quality and Regulatory

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA

Teaching the Plant

Abhinav Arora

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta

Sponsored by Particle Measuring Systems

Normalized Data in Microbial Continuous Monitoring

Rosa Laronga Giulia Paternò Serena Steidl

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

Walter Morris, PDA

Beyond the Limits

Yanet Flor

More Articles

Supply Chain and Outsourcing

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

PDA Manufacturing Meets Legislation

Dr. Bettine Boltres Ana Marques Kuschel, PhD

The High Cost of Cheap Drugs

Martin VanTrieste

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

Jason Kerr Katie Bevard Maria Jacobs, PhD, Pfizer, Inc.

More Articles

PDA Letter's Top Articles

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker, Kymanox Corporation

Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.
Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Facilitating Adoption of Modern Microbial Methods

Lynn Johnson, MicroCompliance Solutions, LLC
Process Hold Times: What is it and Why is it Important?

Robert Dream, MS, Nivagen Pharmaceuticals and Bruce Loxley, GSK

Recent Articles (Past 60 Days)

Sponsored by Particle Measuring Systems
Normalized Data in Microbial Continuous Monitoring

Rosa Laronga, Particle Measuring Systems , Giulia Paternò, Particle Measuring Systems , and Serena Steidl, Particle Measuring Systems

News Brief: FDA Cracks Down on Misleading Drug Ads

Justin Johnson, PDA
Teaching the Plant

Abhinav Arora

FDA Expands Use of Unannounced Foreign Inspections

Louise Uí Fhatharta, Pharmalex

Who Picked That Supplier?

Dr. Jane Zhang, ETCH Sourcing , Nazifa Rahman, ETCH Sourcing , and Anna Schniepp, ETCH Sourcing

The PDA Regulatory Conference Features Over 30 FDA Experts on the Agenda

Walter Morris, PDA
Beyond the Limits

Yanet Flor, GMP Check Solutions

News Brief: FDA Announed FDA PreCheck

Justin Johnson, PDA
News Brief: PDA AI Glossary Now Available

Walter Morris, PDA
Supply Challenges and Future Technologies in 2025

Deirdre Tobin, Compass Pharma Consulting Ltd and Connie Leech, CAI

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines
Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker, Kymanox Corporation

News Brief: U.S. FDA Head Makary Says Severity of FDA Layoff Overstated

Walter Morris, PDA
News Brief: Sean Keveney Appointed Chief Counsel of FDA

Justin Johnson, PDA
Equivalence Testing of BFPCs in Grade A Environments

Mads Lichtenberg, PhD, Fujifilm Biotechnologies, et. al.
Community News Quarterly | July 2025

PDA
Harnessing HACCP for Aseptic Filling

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

News Brief: FDA Appoints Dr. George Tidmarsh as Director of CDER

Walter Morris, PDA