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Members-only Articles

Enhancing Consistency in Environmental Monitoring: Addressing Variability in Surface Sampling
Vanessa Figueroa, VVF Science and Josh Erickson, M.S., US Pharmacopeia

Alternative Method Audit Preparation
Allison Scott, BWT Pharma & Biotech Inc, et al.

Leadership, Layoffs, and Legislation
Katie Bevard, Eli Lilly

News Brief: U.S. FDA Launches AI Tool, Elsa
Justin Johnson, PDA

Engineering Excellence in Container Closure Integrity Testing
Oliver Stauffer, PTI

News Brief: AI and Reshoring Topic of One-Day DC Event
Walt Morris, PDA

PDA Europe and EMA Unite
Toni Manzano, PhD, PDA Knowledge Management Roadmap Task Force

The mRNA Revolution
Amisha Patel, Sanofi

PDA Spotlight: The Power of Networking and Innovating
PDA

Bridging Academia and Industry
Renee Morley, MBA, Contec, Inc.

News Brief: Successful AI Pilot Prompts FDA to Launch Full-Scale Integration
Justin Johnson, PDA

News Brief: EMA and HMA Joint Workplan on Data and AI in Medicines Regulation
Walter Morris, PDA

The Need for Manufacturing Speed
Michael Anyadiegwu, PhD , Renske Hesselink, PhD , and Ingrid Kromann, CEPI

News Brief: President Trump Plans Actions to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
Justin Johnson, PDA

PDA Puerto Rico Chapter Reignites
PDA Puerto Rico Chapter

A Toolbox for an Effective Technology Transfer
Rui Almeida, ValGenesis

Microneedle Array Patches for Vaccine Delivery
Mahmoud Ameri, PhD,, Americeutics Consulting , James Birchall, Cardiff University , and Andrew Riso, Kindeva Drug Delivery

News Brief: FDA/CDER Accepting QMM Prototype Assessment Requests Until June 9
PDA

Community News Quarterly | April 2025
PDA

News Brief: U.S. FDA Announces Limits to Industry Employees Serving on FDA Advisory Committees
Walter Morris, PDA

News Brief: Dept. Commerce Seeks Comment on Pharma Import Risks
Walter Morris, PDA

Expert Perspectives in KM Between Sponsors and Third Parties
Dr. Bettine Boltres , Danica Brown , Beth Haas , Marty Lipa , Rhonda Sundberg , and Joseph Thomas, PDA Knowledge Management Roadmap Team

Get Ecstatic for Aseptic
David Keen, Ecolab Life Sciences

Bioburden Monitoring for Primary-Packaging Sterile Manufacturing
Bart Moens, Organon

Nominations for PDA Board of Directors Open until May 1
PDA, Inc.

Ethical Dilemmas in Pharma: Pharma's Toughest Decisions
Martin VanTrieste, Civica Rx

Understanding the UK’s International Recognition Procedure
Claire Stevenson, PhD, PharmaLex and Aashni Shah, PharmaLex

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, STERIS

Global Regulatory Convergence — What If?
Glenn Wright, PDA

Bridging the Gap Between Employers and Early Career Professionals to Succeed Together
Justin Johnson, PDA

Knowledge Management and its Relation to Data Integrity
Kristen Anderson, PhD , Klaus Finneiser , Kir Henrici, The Henrici Group , Megan Powdrill , and James L. Vesper, PhD, PDA Knowledge Management Roadmap Team

From Lab to Market
Tejesh Marsale, PCI Pharma Services

Embracing Change: Catalysts for Disruption
Justin Johnson, PDA

Key Steps to Commercialization Readiness in Europe
Frederic Pailloux, PharmaLex

Uncovering the Symbiotic Link Between KM and AI
Marty Lipa , Anne Greene , Paige Kane , Michele Simone, PhD, Bracco , and Toni Manzano, PhD, PDA Knowledge Management Roadmap Task Force

Advancing the Industry Dialogue on KM in Support of PQS Effectiveness
Marty Lipa and James L. Vesper, PhD, PDA Knowledge Management Roadmap Team

PDA to Launch First-of-its-Kind Ethics Course on Pharma Manufacturing
Glenn Wright, PDA

Shaping the Future of Injectable Medicine Inspection
Rick Watson, Merck and Romain Veillon, GSK

Five Important Insights from the PDA Europe Annex 1 Event
Patrick Nieuwenhuizen, PharmaLex

Benefits and Opportunities of Using the PDA AI Glossary
Toni Manzano, PhD, PDA Knowledge Management Roadmap Task Force , Hue Kwon, PhD, Sobi , and Sabine Hauck, Consultant

GMP Annex 1 Implementation
Andrea Salmaso, Stevanato Group

The 2025 Kilmer Conference
Michael Sadowski, Sterilexcellence

Parenteral Packaging Conference Explores Transformative Change
Philippe Lauwers, Terumo Pharmaceutical Solutions and Coralie Richard, Eli Lilly and Company

Community News Quarterly | January 2025
PDA

News Brief: FDA CDER Director Patrizia Cavazzoni Announces Resignation
Walter Morris, PDA

News Brief: More FDA Guidances for the New Year
Walter Morris, PDA

News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance
Justin Johnson, PDA

Modern Microbial Methods Supporting a Contamination Control Strategy
Allison Scott, Particle Measuring Systems, et al.

Points to Consider When Applying QRM
Douglas Campbell, InterPro QRA

How AI and ML Is Getting Integrated into Life Sciences Companies
Michael de la Torre

Biopharmaceutical Manufacturing Conference
Louise Uí Fhatharta, Pharmalex

Knowledge-Driven Impurity Control for NMF Protein Products
Qifeng Zhang, PhD, Lonza, Lonza Biologics

On The Issue: Brent Watkins on Aseptic Processing
PDA

Important Takeaways from the PDA/FDA Joint Regulatory Conference
Justin Johnson, PDA

Breaking point: Assessing and Addressing the Risk of Auto-Injector Failure
Enrico Barichello, Stevanato Group

The Latest Current FDA CBER Initiatives
Edward H. Trappler, Lyophilization Technology, Inc. and Denise Miller, Lyophilization Technology

On The Issue: The 2024 Innovation Awards
PDA

Sprinting Toward the Lab of the Future: Practical Steps to Get Started
Ashley McMillan, Veeva Vault LIMS

Transforming Pharmaceutical Inspections with Human-Like Robot AI
Romain Veillon, GSK

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

On The Issue: The Sustainability IG
PDA

Cross-Industry Insights: Leveraging Quality-Enabling Behaviors for Success
Jason Kerr, Moderna

PDA Southeast Chapter State Ambassador Program
Austin Caudle, Project Farma

Microbial Ingress No Longer an Effective CCI Test Method
Oliver Stauffer, PTI and Tyler Harris, PTI

Sartorius and PDA India Chapter Honors Late Amit Sharma with Inaugural Scholarship Program
Vishal Sharma, MS, Vienni Training and Consulting LLP

2023 PDA Honor Awards: Honorary Membership
PDA

Navigating New Horizons: Discoveries from the 2024 PDA Annual Meeting
Michelle Tu, Qvin

Community News Quarterly | October 2024
PDA

Understanding Japan Quality
Antonio Burazer, Takeda

PDA Manufacturing Meets Legislation
Dr. Bettine Boltres and Ana Marques Kuschel, PhD, WEST Pharmaceutical Services

2023 PDA Honor Awards: Service Appreciation Award
PDA

The High Cost of Cheap Drugs
Martin VanTrieste, Civica Rx

Anticipating the 19th PDA Pharmaceutical Microbiology Conference 2024
Kurt Jaecques, MS, GSK and Erika Pfeiler, PhD, U.S. FDA

Behind the Scenes of the Alternative Microbiological Methods Workshop
PDA

Innovation in Injectables
Laurent Jeanmart, PhD, GSK and Brigitte Reutter-Haerle, Vetter Pharma

News Brief: FDA’s Reorganization Plan Comes into Focus at PDA/FDA Joint Regulatory Conference
Walter Morris, PDA

PDA Spotlight: FDA Compounding
PDA

News Brief: Navigating Regulatory Uncertainty
Justin Johnson, PDA

Validating NGS-Based Assays In-House for Virus Safety Assessment
Christoph Bredack, PhD, Genedata

PDA Launches New Journal Submission Tool
Whitney Alexis, PDA

On The Issue: Canada Chapter
PDA

Process Hold Times: What is it and Why is it Important?
Robert Dream, MS, Consultant and Bruce Loxley, GSK

New Training Course – Manage your Aseptic Filling Line
Julian Petersen, groninger & co. gmbh

2023 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards
PDA

Keep Aseptic Conditions Continuity within Transfer Procedures
Lucia Ceresa, Consultant

Yes, Men Get Breast Cancer, too – Perspective is a Funny Thing
Glenn E. Wright, PDA President and CEO

Behind the Scenes of the PDA Combination Products Workshop
PDA

PDA Hosts Industry Focused Roundtable on Speeding Innovation through Global Regulatory Convergence
Glenn E. Wright, PDA President and CEO

Navigating the CDMO-Sponsor Partnership
Morten Munk, FUJIFILM Diosynth Biotechnologies , Virginia Boldt, Accenture , and Andrew Chang, PhD, PhD, Novo Nordisk

PDA BioManufacturing Conference 2024 Lands in Gothenburg, Sweden
Sabine Hauck, Consultant and Elisabeth Vachette, Sartorius Stedim Biotech

An Alternative and Sustainable BET Designed for Patient Safety
Parampal Deol, PhD, Charles River Laboratories

2023 Honor Awards: Outstanding Early Career Professional Awards and President's Awards
PDA

Find out what to expect from the PDA/FDA Joint Regulatory Conference
PDA

2023 PDA Honor Awards: Chapter of the Year Award
PDA

News Brief: USP Adopts Recombinant Reagents for BET; Draws Commendations
Walter Morris, PDA

On The Issue: The West Coast Chapter
PDA

Industry Expert Discusses the Value of the PDA/FDA Joint Regulatory Conference 2024
PDA

How Best to Act Locally to Manage Globally in Aseptic Processing
PDA

2023 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards
PDA