PDA Letter
Sponsored by Ecolab
Driving Continuous Improvement: Pushing Through the Barriers to Change

By: Matt Cokely, Ecolab Life Sciences

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: CanadaChapter

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, Inc.

News Brief: USP Adopts Recombinant Reagents for BET; Draws Commendations

Walter Morris, PDA, Inc.

On The Issue: The West Coast Chapter

PDA, Inc.

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, 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, 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, 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 and 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, 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, Inc.

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: Maria Jacobs, PhD, Pfizer, Inc. , Katie Bevard, Amgen , and Jason Kerr, Moderna, Redica Systems

A Comprehensive Review of Regulatory Intelligence and Its Framework

By: Jason Kerr, Moderna, Redica Systems , Maria Jacobs, PhD, Pfizer, Inc. , and 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 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, 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, Lonza Biologics

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, Eli Lilly Italia, S.p.A

To See or Not to See?

By: Andrea Sardella, National Research Council, Stevanato Group and Hanns-Christian Mahler, PhD, ten23 health, ten23 health

Advanced Nucleic Acid Testing Methods Rise to the Challenge

By: Manjula Aysola , Danielle DiTirro , Pamela Hamill , and Alison Armstrong, MIlliporeSigma

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