

- Front Page
- About
- Multimedia
- Submit
Members-only Articles

Understanding the UK’s International Recognition Procedure
By: 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, PDA

Challenges in Sterilizing Indirect Product-Contact Surfaces
By: Cecilia Pierobon, STERIS

Global Regulatory Convergence — What If?
By: 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
By: Kristen Anderson, PhD , Klaus Finesser , Kir Henrici, The Henrici Group , Megan Powdrill , and James L. Vesper, PhD, PDA Knowledge Management Roadmap Team

From Lab to Market
By: Tejesh Marsale, PCI Pharma Services

Embracing Change: Catalysts for Disruption
Justin Johnson, PDA

Key Steps to Commercialization Readiness in Europe
By: Frederic Pailloux, PharmaLex

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

Advancing the Industry Dialogue on KM in Support of PQS Effectiveness
By: 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
By: Rick Watson, Merck and Romain Veillon, GSK

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

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

GMP Annex 1 Implementation
By: Andrea Salmaso, Stevanato Group

The 2025 Kilmer Conference
By: Michael Sadowski, Sterilexcellence

Parenteral Packaging Conference Explores Transformative Change
By: 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News Brief: FDA Releases Draft Guidance on 21 CFR 211.110 Compliance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
By: Douglas Campbell, InterPro QRA

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

Biopharmaceutical Manufacturing Conference
By: Louise Uí Fhatharta, Pharmalex

Knowledge-Driven Impurity Control for NMF Protein Products
By: 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
By: Enrico Barichello, Stevanato Group

The Latest Current FDA CBER Initiatives
By: Edward H. Trappler 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
By: Ashley McMillan, Veeva Vault LIMS

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

Q&A on the Revised PDA Technical Report No. 22
By: Subrata Chakraborty, GxPfont Consulting Group , Vanessa Figueroa, VVF Science , and Marcia C Baroni, Emergent BioSolutions Inc

On The Issue: The Sustainability IG
PDA

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

PDA Southeast Chapter State Ambassador Program
By: Austin Caudle, Project Farma

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

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

2023 PDA Honor Awards: Honorary Membership
PDA

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

Community News Quarterly | October 2024
PDA

Understanding Japan Quality
By: Antonio Burazer, Takeda

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

2023 PDA Honor Awards: Service Appreciation Award
PDA

The High Cost of Cheap Drugs
By: Martin VanTrieste, Civica Rx

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

Behind the Scenes of the Alternative Microbiological Methods Workshop
PDA

Innovation in Injectables
By: Laurent Jeanmart, PhD, GSK and Brigitte Reutter-Haerle

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
By: 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?
By: Robert Dream, Consultant and Bruce Loxley, GSK

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

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

Keep Aseptic Conditions Continuity within Transfer Procedures
By: 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
By: Morten Munk, FUJIFILM Diosynth Biotechnologies , Virginia Boldt, Accenture , and Andrew Chang, PhD, PhD, Novo Nordisk

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

An Alternative and Sustainable BET Designed for Patient Safety
By: 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

Sneak Preview of PDA Universe of Pre-Filled Syringes and Injection Devices Conference
PDA

A Holistic Approach to CCI is a Deterministic Approach
By: Oliver Stauffer, PTI

Pathway to a Contamination Control Strategy
By: Londa Ritchey and Patrick Nieuwenhuizen, PharmaLex

Community News Quarterly | July 2024
PDA

News Brief: SCOTUS Chevron Deference Decision is a Seismic Shift in the Regulatory Landscape
Walter Morris, PDA

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making
Justin Johnson and Walter Morris, PDA

On The Issue: The Power of AI in CGMP Manufacturing
PDA

Vaccine Experts’ Voice at the 2024 PDA Week
By: Cristiana Campa, PhD, Technical R&D Advisor at GSK and Sabrina Restrepo, Merck & Co.

2023 PDA Honor Awards: Europe and Asia Pacific Appreciation Awards
PDA

10 Museums Emphasizing Microbiology Worthy of a Visit
By: Tony Cundell, PhD, Microbiological Consulting, LLC

Unleashing the Power of AI
By: Tejesh Marsale, PCI Pharma Services

2023 PDA Honor Awards: Distinguished Service Award
PDA

Revolutionizing QRM: The Impact of AI and ML
PDA

Driving Positive Change in Pharmaceutical Manufacturing
Justin Johnson, PDA

2023 PDA Journal Article of the Year
PDA

Meeting the ATMP Moment with Robotics and Automation
By: Josh Russell, AST

On The Issue: Sustainability in ADC Manufacturing
PDA

A Path Towards Improved Training Outcomes and Better GxP Compliance
By: Kent Malmros, Veeva Training Strategy and Iain Searle, Veeva Training Strategy

A Promising Path Forward: A Reflection of the 2024 PDA Annual Meeting
Justin Johnson, PDA

GoodFellas: Hal Baseman and Stephan Roenninger are PDA’s Technical Fellows
Walter Morris, PDA

Second Book in PDA – Euromed Communications Series Now Available
PDA

2023 PDA Letter Article of the Year
PDA

PDA Spotlight Podcast Episode 5: Board of Directors Series
PDA

Celebrating a Decade of Excellence
By: Emily Cheah, PhD, Charles River Laboratories-Singapore

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies
By: Stephan Krause, PhD, Bristol Myers Squibb and Adam Boyer, Bristol Myers Squibb, Bristol Myers Squibb

Aseptic Transfers to Grade A
By: Julian Petersen, groninger & co. gmbh and Richard Denk, SKAN AG