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Members-only Articles
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 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, Redica Systems
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: Bettine Boltres, PhD, West Pharmaceutical Services 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 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: Jason Kerr, Moderna , Katie Bevard, Amgen , and Maria Jacobs, PhD, Pfizer, Inc.
A Comprehensive Review of Regulatory Intelligence and Its Framework
By: Jason Kerr, Moderna , Katie Bevard, Amgen , and Maria Jacobs, PhD, Pfizer, Inc.
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.