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Members-only Articles
Driving Continuous Improvement: Pushing Through the Barriers to Change
By: Matt Cokely, Ecolab Life Sciences
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 Nieuwenhuize, 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, 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
On The Issue: PDA India Chapter
PDA, Inc.
Points to Consider on Aseptic Filling Technologies Nearing Completion
By: Rebecca Brewer, Quality Executive Partners
Welcome New PDA Germany/Austria/Switzerland Chapter!
By: Julian Petersen, groninger & co. gmbh
Intrinsic Sterile Connection Devices
By: William Peterson, Merck
Digitization Advancing in the Near Future
By: Toni Manzano, Aison
Nominations for PDA Board of Directors Open to May 8
PDA, Inc.
Legacy Filling Lines Evolve
By: Ahmed Elsaid, Emergent Biosolution and Ajay Pazhayattil, PhD, cGMP World
Community News Quarterly | April 2024
PDA
On The Issue: PDA Training
PDA, Inc.
Building a Quality Culture Using Quality Systems
By: Ron Branning, GXP Quality Systems, LLC, GXP Quality Systems, LLC
The Annex 1 2022 Revision: A Success Story, Still to be Written
By: Hal Baseman, ValSource, Inc. and Gabriele Gori, Independent Consultant
The Key to Compliance with Annex 1 and Risk Based Regulations
By: Noelle Clifford, PharmaLex, PharmaLex
A View on the Revised Annex 1
By: Antonio Burazer, Takeda , Alexander Artau, Sanofi , Elisabeth Wagner, CSL Behring , and Joseph Straub, Merck
Elevating Sterile Manufacturing
By: Simone Biel, PhD, Merck, Merck
The14th Parenteral Packaging Conference
By: Philippe Lauwers, Terumo Pharmaceutical Solutions
Sterility Testing of Cell and Gene Therapies
By: Zachary Beck, Eurofins
On The Issue: The Quality Management Maturity Model
PDA, Inc.
A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities
By: Maria Jacobs, PhD, Pfizer, Inc. , Katie Bevard, Amgen , and Jason Kerr, Moderna, Redica Systems
A Comprehensive Review of Regulatory Intelligence and Its Framework
By: Jason Kerr, Moderna, Redica Systems , Maria Jacobs, PhD, Pfizer, Inc. , and Katie Bevard, Amgen
Multiverse of Manufacturing Challenges: A PDA Annual Meeting Session
Walter Morris, PDA, Inc.
Biosafety Guidelines for Handling Microorganisms in Microbiology Laboratories
By: Tony Cundell, PhD, Microbiological Consulting, LLC
Next Steps in ATMPs and Beyond
By: Renske ten Ham, PhD, UMC Utrecht and Richard Denk, SKAN AG
Strategic Alliances: A Preview of the PDA Workshop on Choosing the Right CDMO Partner
By: Maria Amaya, Genentech
Excitement in the Air: Anticipating PDA Week 2024 in Southern California
By: Sebastian B. Teitz, PhD, Freelancing
PDA Spotlight Podcast Episode 3: Board of Directors Series
PDA
Chair’s Message: Continuing to Shape the Future of Pharmaceutical Manufacturing
By: Anil Sawant, PhD
Current Challenges and Control Strategies for Polysorbates in Biopharmaceuticals
By: Roman Mathaes, PhD, Lonza
On The Issue: A Talk with Pulitzer Prize Winner Dominic Gates: Quality Culture
PDA, Inc.
Knowledge-Driven Rapid Analytics for New Molecular Format Protein Therapeutics
By: Qifeng Zhang, PhD, Lonza, Lonza Biologics
Microbial Control During Low-Risk Aseptic Processing
PDA Staff Author: David Jaworski, MBA, PDA, Inc.
PDA Annual Meeting 2023: Student Voices
By: Ashutosh Anand, GSK
PDA Italy Chapter Announces Student Awards
By: Mauro Giusti, PhD, Eli Lilly Italia, S.p.A
To See or Not to See?
By: Andrea Sardella, National Research Council, Stevanato Group and Hanns-Christian Mahler, PhD, ten23 health, ten23 health
Advanced Nucleic Acid Testing Methods Rise to the Challenge
By: Manjula Aysola , Danielle DiTirro , Pamela Hamill , and Alison Armstrong, MIlliporeSigma
Simplicity Wins with Combo Products: An Interview with Jim Collins
PDA Staff Author: Justin Johnson
Effective Strategies for Investigating Media Fill Failures in Sterile Manufacturing
Niravbhai Patel, PhD, and Dhavalkumar Surti, Nivagen Pharmaceuticals, Inc.
On The Issue: 2023 Partnership Award Winners
PDA, Inc.
Seven Key Takeaways from PDA’s Viral Safety for ATMPs Workshop and Virus Conference Events
Alison Armstrong, PhD, Merck KGaA, Andy Bailey, ViruSure, Sean O’ Donnell, PhD, Eli Lily, and Sebastian Teitz, Biopharma Excellence
Congratulations to the Winners of the 2023 Drug Delivery Innovation Awards!
On The Issue: 2023 PDA Drug Delivery Innovation Award
PDA, Inc.
On The Issue: The Digitalization IG & Task Force
PDA, Inc.
Opinion: Revisit Regulatory Expectations for Micro ID in Grade A Environments for Non-growth-based Methods?
Petra Merker, PhD, Bayer AG, Tony Cundell, PhD, Microbiological Consulting, LLC, and Cynthia Martindale, Applied Rapid Microbiology Specialists, Ltd.
PDA Spotlight Podcast Episode 2: Board of Directors Series
PDA
Challenges of Analytical Method Validation for ATMPs
Patrick Nieuwenhuizen and Christopher Rogers, PharmaLex
In Memoriam: Immediate-Past Chair Jette Christensen
PDA, Inc.
Change for Good, Be a Disrupter!
James Agalloco, Agalloco & Association