PDA Letter
On The Issue: The Quality Management Maturity Model

PDA, Inc.

A Comprehensive Review of Regulatory Intelligence: Exploring Tools and Program Maturities

By: Jason Kerr Katie Bevard Maria Jacobs

A Comprehensive Review of Regulatory Intelligence and Its Framework

By: Jason Kerr Maria Jacobs Katie Bevard

Multiverse of Manufacturing Challenges: A PDA Annual Meeting Session

Walter Morris, PDA, Inc.

Opinion: Biosafety Guidelines for Handling Microorganisms in Microbiology Laboratories

By: Tony Cundell, PhD

Next Steps in ATMPs and Beyond

By: 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 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

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

Microbial Control During Low-Risk Aseptic Processing

PDA Staff Author: David Jaworski, MBA

PDA Annual Meeting 2023: Student Voices

By: Ashutosh Anand

PDA Italy Chapter Announces Student Awards

By: Mauro Giusti, PhD

To See or Not to See?

By: Andrea Sardella Hanns-Christian Mahler

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

Don’t Miss the 2023 PDA Good Aseptic Manufacturing Conference!

Kerstin Wilken, IDT Biologika, and Paul Devuyst, GSK

Join Us at the 2023 Visual Inspection Forum

John Shabushnig, PhD, Insight Pharma Consulting, and Romain Veillon, GSK

Robotics and Automation in Pharmaceutical Production

Andrea Tanzini, Staubli Robotics

Making Connections to Last a Lifetime

Shannon Sperati, PDA, Inc.

We're Going to New Orleans! Let’s Talk about Contamination Control and the Annex 1 Revision

Justin Johnson