PDA Letter
Sponsored by U.S. Pharmacopeia
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