PDA Letter

Features | Aseptic Processing

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

David Jaworski, MBA

Setting the Standard

Katharina Schlereth

Understanding FDA Complete Response Letters

Justin Johnson, PDA
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Aseptic Processing & Sterilization

Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Optimizing Cleanroom Disinfection

Karan Khairnar, MS

Preventing Condensation in Cleanrooms

Tony Cundell, PhD, Microbiological Consulting, LLC

Setting the Standard

Katharina Schlereth

HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB

Managing Ready-to-Use (RTU) Containers in Aseptic Production Facilities

Alliance for RTU and IMA Life

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Biopharmaceuticals & Biotechnology

News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA

Navigating the AI Landscape

Peter Makowenskyj, MEng Toni Manzano

Driving Innovation in Pharma

Antonella Maggio Beth Haas Vinny Browning III

Accelerating Progress: How PDA Drives AI Innovation in Healthcare

Andrew Chang, Novo Nordisk, et al.

From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

Disruption Potential of Injectable Anti-Obesity Therapies and Beyond

Mathias Romacker

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Manufacturing Science

Sponsored by Veolia

Validating Recombinant Endotoxin Reagents

Meg Provenzano

MHRA’s Decentralized Manufacturing Regulation Set to Take Effect

Munyaradzi Japondo

Teaching the Plant

Abhinav Arora

Beyond the Limits

Yanet Flor

News Brief: PDA AI Glossary Now Available

Walter Morris, PDA

From Lab to Market

Tejesh Marsale

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People

On The Issue: Cristiana Campa Discusses Second Edition of Bestselling QbD Book

PDA

Students Step Beyond the Classroom

Tita Tavares, PDA

On The Issue: Marcia Baroni Discusses Newly Released TR-22

PDA

Reigniting PDA Puerto Rico

Justin Johnson, PDA

On The Issue: IPM Microbiology, A Talk with the Editors

PDA

A New Era for the PDA Journal

PDA JPST Editorial Team

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Quality and Regulatory

Understanding FDA Complete Response Letters

Justin Johnson, PDA

Building Maturity and Resilience Through Quality Culture

Annette Boland

PDA Capital Area Chapter Roundtable on Complete Response Letters Draws a Large Sunday PM Audience

Walter Morris, PDA

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA

From Warp Speed to Uncertainty: U.S. Vaccine Policy in Crisis

Anya Hillery, PhD, Freelance Medical Writer

The New Normal at the FDA

Katie Bevard

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Supply Chain and Outsourcing

News Brief: FDA Launches Pilot Program to Boost U.S. Generic Drug Production

Justin Johnson, PDA

Who Picked That Supplier?

Dr. Jane Zhang Nazifa Rahman Anna Schniepp

Supply Challenges and Future Technologies in 2025

Deirdre Tobin Connie Leech

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.

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PDA Letter's Top Articles

News Brief: FDA Unveils New Tools to Evaluate Drug Manufacturing Sites

Justin Johnson, PDA
HEPA Filter Management—Industry Survey Results

Brandon L. Stiff, CSSBB, Merck & Co.

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

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

Subrata Chakraborty, PhD, INOVR , Vanessa Figueroa, VVF Science , and Marcia C. Baroni, MBA, Emergent BioSolutions Inc

PUPSIT and the Annex 1 Revision

Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource

Recent Articles (Past 60 Days)

On The Issue: Cristiana Campa Discusses Second Edition of Bestselling QbD Book

PDA
Three Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Students Step Beyond the Classroom

Tita Tavares, PDA
Optimizing Cleanroom Disinfection

Karan Khairnar, MS, Ecolab Life Sciences

Preventing Condensation in Cleanrooms

Tony Cundell, PhD, Microbiological Consulting, LLC

On The Issue: Marcia Baroni Discusses Newly Released TR-22

PDA
News Brief: FDA Expands AI with Agentic Deployment

Justin Johnson, PDA
Setting the Standard

Katharina Schlereth, Labor LS

Reigniting PDA Puerto Rico

Justin Johnson, PDA
Navigating the AI Landscape

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

Understanding FDA Complete Response Letters

Justin Johnson, PDA
On The Issue: IPM Microbiology, A Talk with the Editors

PDA
Driving Innovation in Pharma

Antonella Maggio, Lesirg Consultants Inc. , Beth Haas, Haas Pharma Consulting LLC , and Vinny Browning III, Amgen, Inc.

Building Maturity and Resilience Through Quality Culture

Annette Boland, PharmaLex

A New Era for the PDA Journal

PDA JPST Editorial Team