PDA Letter
Sponsored by Contec, Inc.
Disinfectant Residues: Mitigation and Management

By: Renee Morley, Contec, Inc.

How Best to Act Locally to Manage Globally in Aseptic Processing

PDA, Inc.

2023 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

PDA, Inc.

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

PDA, Inc.

Pathway to a Contamination Control Strategy

By: Londa Ritchey Patrick Nieuwenhuize, PharmaLex

Community News Quarterly | July 2024

PDA, Inc.

News Brief: SCOTUS Chevron Deference Decision is a Seismic Shift in the Regulatory Landscape

Walter Morris, PDA, Inc.

FDA/CDER Readying Draft Guidance on AI to Support Regulatory Decision-Making

Justin Johnson and Walter Morris, PDA, Inc.

On The Issue: The Power of AI in CGMP Manufacturing

PDA, Inc.

Vaccine Experts’ Voice at the 2024 PDA Week

By: Cristiana Campa, PhD Sabrina Restrepo

2023 PDA Honor Awards: Europe and Asia Pacific Appreciation Awards

PDA, Inc.

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, Inc.

Revolutionizing QRM: The Impact of AI and ML

PDA, Inc.

Driving Positive Change in Pharmaceutical Manufacturing

Justin Johnson, PDA, Inc.

2023 PDA Journal Article of the Year

PDA, Inc.

Meeting the ATMP Moment with Robotics and Automation

By: Josh Russell, AST

On The Issue: Sustainability in ADC Manufacturing

PDA, Inc.

A Path Towards Improved Training Outcomes and Better GxP Compliance

By: Kent Malmros, Veeva Training Strategy Iain Searle, Veeva Training Strategy

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

Justin Johnson, PDA, Inc.

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

Walter Morris, PDA, Inc,

Second Book in PDA – Euromed Communications Series Now Available

PDA, Inc.

2023 PDA Letter Article of the Year

PDA, Inc.

PDA Spotlight Podcast Episode 5: Board of Directors Series

PDA, Inc.

Celebrating a Decade of Excellence

By: Emily Cheah, PhD

Manufacturing Capacity Expansion and Validation for Autologous Cell Therapies

By: Stephan Krause, PhD Adam Boyer, Bristol Myers Squibb

Aseptic Transfers to Grade A

By: Julian Petersen Richard Denk

On The Issue: PDA India Chapter

PDA, Inc.

Points to Consider on Aseptic Filling Technologies Nearing Completion

By: Rebecca Brewer

Welcome New PDA Germany/Austria/Switzerland Chapter!

By: Julian Petersen

Intrinsic Sterile Connection Devices

By: William Peterson

Digitization Advancing in the Near Future

By: Toni Manzano

Nominations for PDA Board of Directors Open to May 8

PDA, Inc.

Legacy Filling Lines Evolve

By: Ahmed Elsaid, Emergent Biosolution Ajay Pazhayattil, PhD, cGMP World

Community News Quarterly | April 2024

PDA, Inc.

On The Issue: PDA Training

PDA, Inc.

Building a Quality Culture Using Quality Systems

By: Ron Branning, GXP Quality Systems, LLC

The Annex 1 2022 Revision: A Success Story, Still to be Written

By: Hal Baseman, ValSource, Inc. Gabriele Gori

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

Strategic Alliances: A Preview of the PDA Workshop on Choosing the Right CDMO Partner

By: Maria Amaya

Excitement in the Air: Anticipating PDA Week 2024 in Southern California

By: Sebastian B. 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

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