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Happy Holidays from PDA!

by: PDA, Inc.

Points to Consider When Applying QRM

by: Douglas Campbell

Knowledge-Driven Impurity Control for NMF Protein Products

by: Qifeng Zhang, PhD, Lonza

Sponsored by Particle Measuring Systems
Identifying the Right Particle Counter for Your Application

Particle Measuring Systems
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.
Understanding the “Halo Effect” and Its Impact on You Right Now

Glenn E. Wright, PDA, Inc.
PDA Midwest Chapter’s Parametric Release Event – A Call to Action

Michael Sadowski, Baxter Healthcare Corporation
2021 PDA Honor Awards: PDA President’s Award

PDA, Inc.
On the Issue: PDA Technical Report No. 41 Revised

PDA, Inc.
Investigating Out-of-Specification Results for BET

Hayden Skalski, Sievers Instruments
2022 PDA BioManufacturing Conference Lands in Amsterdam

Co-Chairs Cristiana Campa, PhD, GSK and Raf De Dier, PhD, Janssen
2021 PDA Honor Awards: PDA Publications

PDA, Inc.
Key Takeaways from the PDA Annex 1 Workshop

Patrick Nieuwenhuizen, PharmaLex
2021 PDA Honor Awards: EU, PDA Asia/Pacific Appreciation, and Chapter of the Year Awards

PDA, Inc.
TR-41: The 2022 Revision

Scott Lute, U.S. FDA, Josh Eaton, PDA, Inc., and Kurt Brorson, Parexel International
Highlights of the SBIA Generic Drugs Forum

David Jaworski, PDA, Inc.
PDA Launches New Tiered Membership Structure

Jette Christensen, PhD, Immediate Past Chair
2021 PDA Honor Awards: Outstanding Early Career Professional Award?

PDA, Inc.
A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 2

Ahmed Elsaid, Emergent BioSolutons, and Ajay Pazhayattil, Capcium Inc.
Voices of the Board: PDA Technical Pubs

Mary Oates, PhD
2021 PDA Honor Awards: Service Appreciation Award

PDA, Inc.
Summer Reading: Grab a PDA Book & Leave Your Troubles Behind

PDA, Inc.
PDA BioManufacturing and Lyophilization Conferences: The Start of a Shared Journey

Cristiana Campa, PhD, GSK; Michael R. DeFelippis, PhD, Eli Lilly; Raf De Dier, PhD, Janssen; and Anthony Cannon, MSD

Death by Data Integrity Assessment

Meg Gallwitz, Consultant
2021 PDA Honor Awards: Distinguished Service Awards

PDA, Inc.
A Successful Q-Model for New mRNA Line Commissioning & Qualification: Pt. 1

Ahmed Elsaid, Emergent BioSolutions, and Ajay Pazhayattil, Capcium Inc.
One Reason I am Happy to Write a Recommendation Letter

Tamer Helmy, PhD
Contamination Control Strategies: A Path for Quality & Safety

Subrata Chakraborty, Gxpfont Consulting Group and Hal Baseman, ValSource, Inc.

2021 PDA Honor Awards: VanTrieste, Korczynski and Smith Awards

PDA, Inc.
You Had Micro Questions, FDA Had Big Answers

Marilyn L. Foster, PDA
Parenteral Packaging 2022: A Q&A with the Conference Chairs

PDA Europe
Accelerated COVAX Approvals Maintained Rigorous Review Process

Adam Caruso, Merck & Co.
Merck Streamlines Quality Management with the Cloud

Mike Jovanis, Vice President of Vault Quality at Veeva Systems
Glenn E. Wright Starts as PDA President & CEO in March 2023; Richard M. Johnson to Retire

PDA, Inc.

PDA's Successful Return to In-Person Meetings

PDA, Inc.
Initial Evaluation Roadmap for Modern Microbial Methods

Claire Fritz Briglia, Vedere Solutions LLC, et al.

Voices of the Board: The PDA Foundation

Bettine Boltres, West Pharmaceutical Services
PDA is Updating Its Membership Structure!

Richard Johnson, PDA, Inc.
Rich Levy Retires; Shanker Gupta to serve as Acting JPST Editor

PDA, Inc.
How Ergonomics & Cleaning Reduce Injuries, Contamination in Micro QC Workflows

Kacey Pouliot, Pall Laboratory
The Role of Peer Review in the Success of the PDA Journal of Pharmaceutical Science and Technology

Tony Cundell, PhD, Microbiological Consulting, LLC, and Associate Editor, PDA JPST
Science-Based Approach to CCI Met with Enthusiasm

Michael Edey, Pfizer Inc. and Derek Duncan, Lighthouse Instruments
Long-Distance Leadership: Managing a Remote or Hybrid Workforce the Right Way

Kate Zabriskie, Business Training Works, Inc.
PDA "Just Right" for John Shabushnig

PDA, Inc.
Chair's Message: Busy Week in Dallas Marks Return to Live Events

Susan Schniepp, PDA Chair 2022-2023
PDA Letter Article of the Year

Marilyn L. Foster, PDA, Inc.
Guest Editorial: What Might Have Been

Russell E. Madsen, The Williamsburg Group
PDA Visual Inspection Forum Returns; Lands in Berlin in 2022

John Shabushnig, PhD, Insight Pharma Consulting LLC, and Romain Veillon, PharmD, GSK Vaccines
A supplier's perspective: How can EU GMP Annex I be integrated into the manufacturing of components for container closure systems?

Bettine Boltres, PhD, West Pharmaceutical Services

President's Message: 2021, A Challenging Year for Everyone

Richard M. Johnson, PDA
Past Leader Spotlight: Nikki Mehringer, Volunteered to Volunteer

Walter Morris, PDA Inc.   
Zero Defect – A Competitive Advantage

Ruby Gulati and Snehal Parikh, Roche-Genentech
Taking the Fear Out of Contamination: Surfaces, Water, and Air, Oh My!

Marilyn L. Foster, PDA, Inc.

2021 was a Challenging Year

Jette Christensen, PDA Chair 2020-2021
5 Agreements for Your Future Culture

Jason V. Barger, Consultant
PDA COVID-19 Task Force

Anil Sawant, PhD, Merck & Co.
Inspection Resources Hot Topic during 'Ask the Regulators' at PDA/FDA JRC

Walter Morris, PDA, Inc.
PDA Assists EMA with Survey about Supply Challenges Related to the Availability of Single-Use-System Components

PDA, Inc.
Contamination Control Strategies: You have questions, we have answers

Rafael Beaus, PhD, Azbil Telstar, James N. Polarine, STERIS Corporation, and Benoit Ramond, PhD, Sanofi
Past Leader Spotlight: Rebecca Devine from FDA CBER to PDA Chair

Walter Morris, PDA Inc. 
PDA In Print: Management of Nonconformances for Temperature-Sensitive Products

PDA, Inc.
Thanks, Science!

Marilyn L. Foster, PDA
Annex 1 and the New Revision — Setting New Expectations

Glenn Wright, PDA, Inc.
PDA’s Honor Awards Program

Trevor Swan, PDA
Zero-Particulates Goal Promotes Continuous Improvement

Subrata Chakraborty, GxPFONT Consulting Group
Three Past Chairs Discuss PDA Careers

Walter Morris, PDA Inc.
How to Measure Quality Management Maturity

Denyse Baker, Jeff Broadfoot, Steve Mendivil, Adam Caruso, and Sandra Lueken
NEPDA Awards Its 2021 Scholarships

PDA New England Chapter
Approaches to Data Integrity Assurance: 2021 Workshop

Julie C. Maurhoff, Ultragenyx Pharmaceutical and DI Workshop Planning Committee Member
COVID-19 Puts Focus on Airborne Virus and Pathogenic Microorganism Detection Methods

Diana Patzelt, PhD, Claudia Scherwing, and Tricia Vail, Sartorius
COVID-19 Related Shortages of Manufacturing Components — There is a Way Through!

Denyse Baker, AstraZeneca
COVID-19 and the Need for an LAL Alternative

Elizabeth Baker, JD, Zach Cockrum, Lawrence Niles, PhD, David Mizrahi, PhD, and Ryan Phelan representing member organizations of the Horseshoe Crab Recovery Coalition
My Journey to Japan — Sort Of

Marilyn L. Foster, PDA
Four Scenarios of Regulatory Relief from PAS and CBE-30 for CCS and Component Changes

Don Klein, PhD, DLK Consulting Services, Inc.