Microbiological Readiness During Sterile Drug Development

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

Redefining Functional Suitability for Modern Drug Packaging: USP <382>

Todd Jasinski, West Pharmaceutical Services

EU GMP Annex 1. Implementation of Contamination Control Strategy

Anne Moreau, GSK Vacccines

Ethical Dilemmas in Pharma: Pharma's Toughest Decisions

Martin VanTrieste, Civica Rx

Challenges in Sterilizing Indirect Product-Contact Surfaces

Cecilia Pierobon, STERIS

Process Hold Times: What is it and Why is it Important?

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

PUPSIT and the Annex 1 Revision

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

Transformer-Multimodal Spectral Imaging (TMSI)

Defining Inoculum Size in the Qualification of Microbiological Test Methods

Tony Cundell, PhD, Microbiological Consulting, LLC

Advanced Robotic Technologies Boosting Sterility Assurance in Life-Science Aseptic Processes

PDA Staff Author: David Jaworski, MBA

Community News Quarterly | March 2026

PDA

How do Metrics Relate to Continual Improvement?

Mary Howe, Bristol Myers Squibb , Denyse Baker, Eli Lilly and Company , Richard Love, HarborView LLC , Adam Caruso, Merck & Co., Inc. , and Sandra Lueken, Stride Bio, Inc.

PDA Education – Evolving to Meet the Needs of Our Members and the Industry

Glenn Wright, PDA President and CEO

Microbiological Readiness During Sterile Drug Development

Abu Sadat Muhammod Saiyem, Square Pharmacuetical Limited

PDA Shaping the Future of Vaccines Workshop

Cristiana Campa, PhD, Vaccines Europe , Daniela Stranges, GSK , Caroline Lynar , Kateryna Khmilevska, Vaccines Europe , and Anna Czwarno, Ms.Eng., Vaccines Europe

PDA Staff Author: Falk Klar, PhD

News Brief: FDA Issues Draft Guidance on Responding to FDA Form 483 Observations

Justin Johnson

Redefining Functional Suitability for Modern Drug Packaging: USP <382>

Todd Jasinski, West Pharmaceutical Services

Advanced Sensors for Pharmaceutical Sterile Filling Lines

PDA Staff Author: David Jaworski, MBA

QSIT: Another Regulatory Acronym Bites the Dust

Walt Morris, PDA

Overcoming the Challenges of Metrics Implementation

Denyse Baker, Eli Lilly and Company , Adam Caruso, Merck & Co., Inc. , Mary Howe, Bristol Myers Squibb , and Richard Love, HarborView LLC

The AI Revolution in Drug Discovery

Niravbhai Patel, PhD, Nivagen Pharmaceuticals, Inc.

Harnessing AI to Strengthen Audit Readiness in Pharmaceutical Manufacturing

Abhinav Arora, ReveonAI Lifesciences

From Theoretical Sensitivity to Proven Detection Capability

Oliver Stauffer, PTI and Patrick Dayton, PTI