PDA Letter
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

Let the Good Times Roll in New Orleans!

PDA, Inc.

On The Issue: Philippe Germanaud

PDA, Inc.

Learning from the Past in A Patient-Centric World

Jason Kerr

Key Takeaways from the 2022 PDA Annex 1 Workshop in Dublin

Eilish Kelly and Patrick Nieuwenhuizen, PharmaLex

Joint Regulatory Conference: Bringing Better Innovation and Communication Moving Forward

Londa Ritchey, PharmaLex

Upcoming CCS Workshop — A New Direction in Workshop Design

Glenn Wright, PDA, Inc.

President’s Message: A Bittersweet Farewell

Richard Johnson, PDA

The Complex Process for Sterile Filling and Points to Consider

Mauro Giusti, Eli Lilly Italia, and Rebecca Brewer, QxP

ATMPs and Annex 1: Some Answers, but More Questions

Rebecca Brewer, Quality Executive Partners, and Richard Denk, SKAN on behalf of the PDA Advanced Therapeutics Medicinal Products Advisory Board

Hello PDA! A Formal Introduction to the PDA Letter

Justin Johnson, Editor

Are You Ready for Sustainable Packaging?

Bettine Boltres, PhD, WEST, and Derek Duncan, PhD, LIGHTHOUSE Instruments

Chair’s Message: A New Horizon for Our PDA Members around the World

Susan Schniepp, PDA Chair 2022-2023

Putting AI to the Test with Continued Process Verification

Marilyn L. Foster and Josh Eaton, PDA, Inc.

Modernizing Risk Assessment for Legacy Products

Sanjay Rajpal Sharma, Lupin

Spotlight on PDA Education in India

Biny Joseph, PDA India Chapter, Eduoriens Skill Development, and David Talmage, PDA, Inc.

Turning Annual Product Quality Reviews into a Strategic Advantage

Sofia Lange, Veeva Systems

PDA SoCal Chapter Two-Year Update

Stephanie Lee, Amgen Inc.

On The Issue: Next Gen ATMP Production

PDA, Inc.

PDA Annex 1 Workshop: Six Key Takeaways from the Final Annex 1

Patrick Nieuwenhuizen, PharmaLex

Technological Solutions to Overcome the New Annex 1 Challenges

Marco Bianchi, De Lama S.p.A.

Microbial Control of Raw Materials Used in Pharmaceuticals

David Jaworski, PDA, Inc.

On The Issue: The Future of Batch Records

PDA, Inc.

PDA Announces 2022 Drug Delivery Innovation Awards Winners

PDA, Inc.

Missouri Valley Chapter Dinner Taps Inspections/Annex 1

Patrick Kane, Veltek Associates, Inc. and chapter board member

Look Both Ways Before Hiring

Jill J. Johnson, Johnson Consulting Services

Voice of the Board: Election for Board of Directors — It is time for you to vote!

Jette Christensen, Immediate-Past-Chair

On The Issue: The 2022 PDA ATMP Conference

PDA, Inc.

Digital Transformation without the Transformation

David Hubmayr, Takeda Pharmaceuticals

2021 PDA Honor Awards: Honorary Membership

PDA, Inc.

Advancing the State of the Art & Transforming Innovation into Practice

Kevin Wright, PhD, Procter & Gamble Technical Centres Ltd.

On The Issue: Next Gen Sequencing

PDA, Inc.

2021 PDA Honor Awards: James Agalloco, Gordon Personeus, and Frederick Carleton Awards

PDA, Inc.

2022 PDA Quality & Regulations Conference

Patrick Costello, PhD, AbbVie Pharmaceuticals, and Vinny Browning, III, Amgen (Co-Chairs)

GMP Challenges with Time Limitations in Pharma Manufacturing

Tony Cundell, PhD, Microbiological Consulting, LLC

On the Issue: The PDA Virus Conference Chairs

PDA, Inc.

2022 Universe of Pre-Filled Syringes and Injection Devices Conference

Richard Johnson, PDA, Inc.