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A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities
by: Maria Jacobs, PhD, Pfizer, Inc., Katie Bevard, Amgen, and Jason Kerr, Moderna
A Comprehensive Review of Regulatory Intelligence and Its Framework
by: Jason Kerr, Moderna, Maria Jacobs, PhD, Pfizer, Inc., and Katie Bevard, Amgen
The Key to Compliance with Annex 1 and Risk Based Regulations
By: Noelle Clifford, PharmaLex
A View on the Revised Annex 1
By: Antonio Burazer, Takeda Alexander Artau, Sanofi Elisabeth Wagner, CSL Behring Joseph Straub, Merck
Elevating Sterile Manufacturing
By: Simone Biel, PhD, 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 Jason Kerr, Moderna
A Comprehensive Review of Regulatory Intelligence and Its Framework
By: Jason Kerr, Moderna Maria Jacobs, PhD, Pfizer, Inc. 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 Richard Denk, Skan AG
Strategic Alliances: A Preview of the PDA Workshop on Choosing the Right CDMO Partner
By: Maria Amaya, Roche
Excitement in the Air: Anticipating PDA Week 2024 in Southern California
By: Sebastian Teitz, PhD
PDA Spotlight Podcast Episode 3: Board of Directors Series
PDA, Inc.
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
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, PDA Italy Chapter
To See or Not to See?
By: Andrea Sardella, National Research Council Hanns-Christian Mahler, PhD, ten23 health
Advanced Nucleic Acid Testing Methods Rise to the Challenge
By: Manjula Aysola Danielle DiTirro Pamela Hamill Alison Armstrong
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, Inc.
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
Taking a Data-Centric Approach to Computer Systems Validation
Robin Smallwood, Veeva
PDA Microbiology Conference 2022 Presentation: Answers You Have Been Wanting
Harolyn Clow, Teva Pharmaceuticals, and Don Singer, Ecolab Life Sciences
Building an Effective Data Integrity Program Using Risk Management
Chinmoy Roy, PDA
On The Issue: 2022 PDA Partnership Innovation Award
PDA, Inc.
Reducing Human Error for Manual Visual Inspection
Vanessa Vasadi Figueroa, QxP and VVF Science, and Robert Ferer, QxP
Continuing the Conversation for Better ATMP Development
Virginia Boldt, Accenture, Stephan Krause, PhD, Bristol Myers, and Friedrich von Wintzingerode, PhD, Roche-Genentech
Balancing Act: Human vs. Machine Inspection in Pharmaceutical Manufacturing
Tejesh Marsale, PCI Pharma Services
PDA Spotlight Podcast Episode 1: Board of Directors Series
PDA, Inc.
PDA and FDA Continues Collaboration on QMM Conversation
Mary Howe, Bristol Myers Squibb, and Jason Kerr, Moderna
Aligning Global Regulatory Guidance Documents for Container Closure Integrity
Oliver Stauffer, PTI
2023 PDA Quality & Regulations Conference
Patrick Costello, AbbVie Pharmaceuticals, and Vinny Browning, Amgen (Co-Chairs)
The Importance of Visual Inspection in Injection of Parenteral Drug Products
Izi Bruker, PhD, Kymanox, et al.
Welcome New RAQAB Members
Denyse Baker, Eli Lilly and Company
The European Ban on PFASs
Taras Tim Bredel, Injecto
Testing of the Future
Heike Merget-Millitzer, PhD, Janssen Inc.
Microbiologists and Training: A Crucial Quality Connection
Donald C. Singer, Ecolab, and Radha Tirumalai, PhD, Merck & Co., Inc.
In-Situ Verification of Disinfectant Rotation for Contamination Control
Laura Brennan, Ecolab
Time to Start Using Polypropylene Vials in the Industry
Ajay Pazhayattil, PhD, cGMP World, Prasanna Sagar, PhD, Itaan Pharma, and Praveen Joseph, IPS-Integrated Project Services
The Difficult Task of Solving Contamination Puzzles
Paula Peacos and Kim Sobien, ValSource, Inc.
Artificial Intelligence and Machine Learning in the Early Stage of a Product Life Cycle
By Maria Batalha, Rui Almeida, Ângela Martinho and Daniel Pais, PhD, Valgenesis
Seven Key Takeaways from PDA’s Good Aseptic Manufacturing Conference
Patrick Nieuwenhuizen, PharmaLex
Per- and Polyfluoroalkyl Substances Ban Starting 2027
Ana Kuschel, PhD, West Pharmaceutical Services
Quality Culture Post-Pandemic
Tamer Helmy, PhD
On The Issue: Digitalization of C.C.
PDA, Inc.
2022 PDA Honor Awards: Honorary Membership
PDA, Inc.
Macro Impacts from the Micro-Universe
Kurt Jaecques, GSK, and Vineeta A. Pradhan, U.S. FDA
The 2023 PDA BioManufacturing Conference Lands in Seville, Spain
Cristiana Campa, PhD, GSK, and Elisabeth Vachette, Sartorius Stedim Biotech
2022 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards
PDA, Inc.
In-process Microbial Control During Aseptic Processing – Medium Risk
David Jaworski, PDA, Inc.
Respond to Survey on ECHA Proposed PFAS Restrictions by Aug. 4
PDA, Inc.
Maintaining Compliance with Deviation Reports: A Glimpse into the 2023 PDA Mastering Deviations Workshop
Kate Malachowski, Novavax
2022 PDA Honor Awards: PDA President’s Award
PDA, Inc.
An Uncommon Battle: Living with Chronic Intestinal Pseudo-Obstruction
Justin Johnson, PDA, Inc.
Making The Most of External Signals for Internal Learning and Knowledge Management
Denyse D. Baker, Eli Lilly and Company, Jackie Veivia-Panter, BioCentriq, and Janeen Skutnik-Wilkinson, Moderna, Inc.
In Memoriam: Amit Sharma
Krishna Chandran, Sartorius, and Ivy Louis, VIENNI Training & Consulting LLP
2022 PDA Honor Awards: PDA Publications
PDA, Inc.
In-process Microbial Control During Aseptic Processing (High-Risk)
David Jaworski, PDA, Inc.
On the Issue: The PDA/FDA Joint Regulatory Conference
PDA, Inc.
2023 PDA Particle Control in Biopharmaceuticals
Roman Mathaes, Clear Solutions Laboratories
2022 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards
PDA, Inc.
From Risk Assessment to Employee Training
Vinicius Tarantino, GxP-CC
2022 Honor Awards: Outstanding Early Career Professional Award
PDA, Inc.
On the Issue: The 2022 PDA Micro Conference Co-Chairs
PDA, Inc.
Impactful Pharma Career Day at PSB City Campus
Tee Wei Ling, National University of Singapore, and Shreeyasen Senthilkumar, Carissa Paul and Blythe Therese Ho Qianxian, La Trobe University (PSB Academy)
In Memoriam: Joyce Bloomfield
PDA, Inc.
Cybersecurity and Its Growing Impact on Medical Devices
Bulla Singh, PhD, Khera Consultants Ltd.
On The Issue: Data Integrity with Kir Henrici
PDA, Inc.
2022 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards
PDA, Inc.
How to Establish Effective CCS with TR-90
Frederic Ayers, Eli Lilly and Company
Achieving Top Management’s Interest Through the Use of KPIs and QPIs
Yanet Flor, SQA Services, Inc
Closing the Distance on the Plastics Supply Chain
Kiley Djupstrom, Kilmer Innovations
2022 PDA Honor Awards: Distinguished Service Awards
PDA, Inc.
2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference!
Theresa Bankston, PhD, Beckton Dickenson, and Alessandro Morandotti, Stevanato Group
2022 PDA Honor Awards: Service Appreciation Award
PDA, Inc.
On the Issue: Philippe Germanaud, Part 3
PDA, Inc.
Industry Remains Divided on Quality Management Maturity Proposal
David Jaworski and Josh Eaton, PDA, Inc.
The Evolution of Cleaning and Disinfection Practices Over 20 Years
Walid El Azab, STERIS
2022 PDA Letter Article of the Year
Justin Johnson, PDA, Inc.
Nominations for PDA Board of Directors Accepted until May 8
PDA, Inc.
Are Your Drug or Device Endotoxins Up to Specs?
Edward C. Tidswell, Merck & Co.
Understanding Disinfectant Efficacy for Off-Label Microorganisms
Mark Wiencek, Contec, Inc.
On The Issue: Former Sanofi CQO Philippe Germanaud Part 2
PDA, Inc.
Vaccine Development Discussion at PDA Europe Biomanufacturing Conference
Maxwell De Long, Genetech
The Urgency for Robotization and Automation
Toni Manzano, Aizon, and Dieter Bachman, PhD, J&J
You’re Invited to the 2023 PDA Virus Conference
Alison Armstrong, Merck KGaA, and Andy Bailey, ViruSure