PDA Letter
The Latest Current FDA CBER Initiatives

By: Edward H. Trappler and Denise Miller, Lyophilization Technology

On The Issue: The 2024 Innovation Awards

PDA

Sprinting Toward the Lab of the Future: Practical Steps to Get Started

By: Ashley McMillan, Veeva Vault LIMS

Transforming Pharmaceutical Inspections with Human-Like Robot AI

By: Romain Veillon, GSK

Q&A on the Revised PDA Technical Report No. 22

By: Subrata Chakraborty, GxPfont Consulting Group , Vanessa Figueroa, VVF Science , and Marcia Baroni, Emergent BioSolutions Inc

On The Issue: The Sustainability IG

PDA

Cross-Industry Insights: Leveraging Quality-Enabling Behaviors for Success

By: Jason Kerr, Moderna

PDA Southeast Chapter State Ambassador Program

By: Austin Caudle, Redica Systems

Microbial Ingress No Longer an Effective CCI Test Method

By: Oliver Stauffer, PTI and Tyler Harris, PTI

Sartorius and PDA India Chapter Honors Late Amit Sharma with Inaugural Scholarship Program

By: Vishal Sharma, Vienni Training and Consulting LLP

2023 PDA Honor Awards: Honorary Membership

PDA

Navigating New Horizons: Discoveries from the 2024 PDA Annual Meeting

By: Michelle Tu, Qvin

Community News Quarterly | October 2024

PDA

Understanding Japan Quality

By: Antonio Burazer, Takeda

PDA Manufacturing Meets Legislation

By: Bettine Boltres, PhD, West Pharmaceutical Services and Ana Marques Kuschel, WEST Pharmaceutical Services

2023 PDA Honor Awards: Service Appreciation Award

PDA

The High Cost of Cheap Drugs

By: Martin VanTrieste, Civica Rx

Anticipating the 19th PDA Pharmaceutical Microbiology Conference 2024

By: Kurt Jaecques, GSK and Erika Pfeiler, PhD, U.S. FDA

Behind the Scenes of the Alternative Microbiological Methods Workshop

PDA

Innovation in Injectables

By: Laurent Jeanmart, PhD, GSK and Brigitte Reutter-Haerle

News Brief: FDA’s Reorganization Plan Comes into Focus at PDA/FDA Joint Regulatory Conference

Walter Morris, PDA

PDA Spotlight: FDA Compounding

PDA

News Brief: Navigating Regulatory Uncertainty

Justin Johnson, PDA

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: Canada Chapter

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

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

Walter Morris, PDA

On The Issue: The West Coast Chapter

PDA

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

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

Walter Morris, PDA

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

Justin Johnson and Walter Morris, PDA

On The Issue: The Power of AI in CGMP Manufacturing

PDA

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

Revolutionizing QRM: The Impact of AI and ML

PDA

Driving Positive Change in Pharmaceutical Manufacturing

Justin Johnson, PDA

2023 PDA Journal Article of the Year

PDA

Meeting the ATMP Moment with Robotics and Automation

By: Josh Russell, AST

On The Issue: Sustainability in ADC Manufacturing

PDA

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

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

Walter Morris, PDA

Second Book in PDA – Euromed Communications Series Now Available

PDA

2023 PDA Letter Article of the Year

PDA

PDA Spotlight Podcast Episode 5: Board of Directors Series

PDA

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

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

A Comprehensive Review of Regulatory Intelligence and Its Framework

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

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

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.