PDA Letter
PDA and PDA Letter Plow Ahead

Rebecca Stauffer, PDA

10 Practical Tips for Crisis Management in Pharma Manufacturing

Satya Moturi, PhD, Biological E. Ltd

PDA Honor Awards: Service Appreciation Awards Part I

Rebecca Stauffer, PDA

A Virtual Look at Risk Management for Prefilled Syringes

Anthony Grilli, Focus Laboratories, and PDA Metro Chapter President

Closed System Transfer Devices Prove Hot PDA Topic

Bettine Boltres, PhD, West Pharmaceutical Services, Inc.

CEO Showcases Future of CGT Therapies for PDA Chapter

PDA Capital Area Chapter

3 Approaches to Viral Safety

Thomas R. Kreil, Takeda

Container Closure Integrity Testing with Lauren Lavec

PDA Letter editors

4 Ways to Manage Your Supply Chain and Mitigate Drug Shortages

Dawn MacNeill, MilliporeSigma

Dinner Meeting Addresses Virtual Companies, Preapproval Inspections

Sunil Anklekar, PhD, Lantheus Medical Imaging, and Treasurer, PDA New England Chapter, and Jacklyn Chesny

Visual Inspection Practices of Cleaned Equipment: Part II

Walid El Azab, STERIS, and Stephane Cousin, GSK

Guest Editorial: A Litmus Test for a Culture of Quality

John D. Ayres, MD, Pharma Safety Solutions, LLC

Chapter Covers New Developments in Visual Inspection

Aidan Harrington, Senior Consultant DPS Global, and President-Elect, PDA Ireland Chapter

PDA Comments Address Risk Management Approach to Gene Therapy CMC

Rebecca Stauffer, PDA

New Vial Technology Shows Promise for Manufacturing Productivity

Dawn Watson and Jeff Cremi, Merck & Co., Inc.

PDA Board of Directors Changes

Rebecca Stauffer, PDA

Guest Editorial: Consulting Firms Can Fill in Missing Pieces

Stephanie Gaulding, Pharmatech Associates

Singapore Chapter Elects New Board via Electronic Voting

PDA Singapore Chapter

More Online Content to Help Pharma

Rebecca Stauffer, PDA

Visual Inspection Practices of Cleaned Equipment: Part I

Walid El Azab, STERIS, and Stephane Cousin, GSK Vaccines

The Product Quality Leader Team Part III: Staying Ahead

Stephan Krause, Mariam Khan, Callum Chapman, Rob Gaglione, Andy Spasoff, Anthony Mire-Sluis (all AstraZeneca)

CMO Works Around the Clock to Produce COVID-19 Meds

Rebecca Stauffer, PDA

Connect with Colleagues via PDA

Susan Schniepp, Regulatory Compliance Associates

PDA Study Explores Role of A.I. in CPV

Tony Manzano, bigfinite

Guest Editorial: A Report on the COVID-19 Situation in India

Ivy Louis, Vienni Training and Consulting

PDA Members Recommend ICH Q9 Changes

Hal Baseman, ValSource

Task Group Formed to Craft PDA Quality Culture Standard

Marilyn Foster, PDA

Guest Editorial: We Should Expect Drug Shortages to Get Worse

Martin VanTrieste, President & CEO, Civica Rx

Real-World Applications of Rapid Micro Methods

Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants

Cryogenic Storage Challenges for Container-Closure Systems

Pascal Sircoulomb, ARaymondlife, and Luce Sohier, SCHOTT

Sterility Test Failure Investigations

Rebecca Stauffer, PDA

9 Tips to Make Working Remotely Work for You and Your Employer

Jill J. Johnson, Johnson Consulting Services

Qualification of Manual Visual Inspection Still Critical

Alexis Flaquiere and Jean Malthête, GSK Vaccines

New Look for the PDA Letter! Plus, All New Content Unlocked

Rebecca Stauffer, PDA

The Product Quality Leader Team Part II: Getting Ahead

Stephan Krause, PhD; Mariam Khan; Callum Chapman; Rob Gaglione; Andy Spasoff; Anthony Mire-Sluis, AstraZeneca

Moving Beyond “Grande-Sized” Manufacturing for Gene Therapies

Rebecca Stauffer, PDA

PDA Responds to the Novel Coronavirus Situation

Richard Johnson, PDA President

Tools to Address Human Error Reduction

Tony Yang, Communications Board Chair, Pacific Northwest Chapter

40 Years of Visual Inspection: Where Do We Go from Here?

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

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part II

Michael De Felippis, PhD, Eli Lilly, and Cristiana Campa, PhD, GSK 

Data Integrity: From the Basics to Big Data

David Hubmayr, CSL Behring

Innovations in Aseptic Processing

Rebecca Stauffer, PDA

Annex 1 to VPHP: The ABCs of Aseptic Processing

Shelly Henderson

Inaugural BioManufacturing Conference Tackles Five Key Issues: Part I

Michael DeFelippis, PhD, Eli Lilly, and Cristiana Campa, PhD, GSK

Board of Directors Nominations Needed

Rebecca Stauffer, PDA

New Decade, New Focus for PDA Letter

Rebecca Stauffer, PDA

Female Biotech Leaders Discuss Their Career Journeys, Offer Advice

Katja Yount, PDA

5.0 Ways Quality 4.0 Will Improve Manufacturing

Snehal Srikrishna, Veeva Systems

Could A.I. Optimize Visual Inspection?

Andreas Gross, Syntegon

4 Questions and 4 Answers About Innovation in Pharma Manufacturing

Rebecca Stauffer, PDA

A Glimpse at FDA’s Micro Regulations

Rebecca Stauffer, PDA

EPA Hearing on EtO Draws Debate

Rebecca Stauffer, PDA

The Product Quality Leader Team Part I: Building the PQL Role

Stephan Krause, PhD; Mariam Khan; Callum Chapman; Rob Gaglione; Andy Spasoff; Anthony Mire-Sluis, AstraZeneca

Panel Inspires Next Generation of Female Biotech Leaders

Tony Yang, Communications Board Chair, Pacific Northwest Chapter

5 Challenges of Closed System Transfer Devices

Cathy Zhao, PhD, and Allison Radwick, PhD, West Pharmaceutical Sciences

PDA Enters 2020 on Strong Note

Jette Christensen, Novo Nordisk

2020 Board of Directors

Rebecca Stauffer, PDA

Joint PDA, IPEC TR Addresses Risk Assessments for Excipients

Eva M. Urban, CSL Behring and M. Schousboe, Novo Nordisk

ICH Q9: Quality Risk Management Revisions on Horizon

Rebecca Stauffer, PDA

Conference Proves “Virtually” Stimulating

Rebecca Kelly, National University of Ireland

FDA Panel Addresses EtO Sterilization

Rebecca Stauffer, PDA

Volunteers Needed for PDA Quality Culture Standard

Christine Alston-Roberts, PDA

Plunging into Six Sigma

Stephenie Overman

Add Sherlock Holmes to Your Investigation Team

Tony Cundell, PhD, Microbiological Consulting, LLC

Get Your Data Integrity Basics Down for Success

Silvia Martins, Five Validation

Robotics and Big Data Key to Lab of the Future

Peter Crane, Synthace

How to Qualify Your Disinfectants

Michael Hodgkinson, Orvera Scientific

FDA Takes Close Look at Innovation

Rebecca Stauffer, PDA

An Inside Look at the 2019 PDA Quality Week

Eva Urban, CSL Behring, Susan Schniepp, Regulatory Compliance Associates, Lori Richter, ValSource, and Ghada Haddad, Merck

Strategic Application of Advanced Analytics for CGT Development

Jennifer Chadwick, PhD, BioAnalytix

Tri-Spine Crab Now on Endangered List

By: James Cooper

Spotlight on Packaging Regulations and CCI

Rebecca Stauffer, PDA

Can We Reprogram the Human Computer?

Rebecca Stauffer, PDA

Publishing Intern Expands Horizons at PDA

Madeline Cusick, Georgetown University

Conference Puts Human Face on Cell and Gene Therapies

Rebecca Stauffer, PDA

Incorporating QRM into Cell and Gene Therapy Processes

Lori Richter, ValSource, and Ghada Haddad, Merck

Avoid Unmixed Process Solutions

Dosung Kim, Jeonghun Kim, Kwangjun Yoon, Denis Rigolet and Anthony R. Newcombe, Polus, Inc.

Life Science Panel Discusses Career Journeys

Christy Wong, Keck Graduate Institute, Student Chapter Communication Chairperson, PDA Southern California Chapter

Are Your RMM Organisms Reflective of Your Process?

Irving Ford, Celgene

PUPSIT and the Annex 1 Revision

Tina Morris, PDA, Maik Jornitz, G-Con, Gabriele Gori, GSK, and Hal Baseman, ValSource

Ready for the Pharma of Tomorrow?

Melissa Seymour, Biogen, and Aaron Goerke, PhD, Roche

Supporting the Quality Risk Management Framework

Denyse Baker, AstraZeneca, and Steven Mendivil, Quality Beyond Compliance

Human Error Causes OOS Investigation

Rebecca Stauffer and Madeline Cusick, PDA

Volunteer Opportunities Abound!

Rebecca Stauffer, PDA

Why is the EU Medical Device Regulation So Critical?

Olivia Henderson, PhD, and Kesley Gallagher, Amgen

Lifecycle Approach Wipes Away Cleaning Validation Concerns

Raji Vathyam

Student Learns Firsthand About Industry

David O’Loughlin, Maynooth University

Exciting Lineup of Speakers at the 2019 PDA/FDA JRC

PDA/FDA Joint Regulatory Conference planning committee

Another Perspective on rFC

Allen Burgenson, Lonza

ISO 22519: A Flawed and Counterproductive Standard

A Team of Pharmaceutical Water Experts

Ireland Chapter Addresses Annex 1 Revision

PDA Ireland Chapter

New Technology Meets Old Data Integrity Challenges

Kir Henrici, The Henrici Group, Monica Cahilly, Green Mountain Quality Assurance, and Peter Baker, Green Mountain Quality Assurance

Follow the Audit Trail Breadcrumbs

Ann Milliman, Baxter Healthcare Corporation

U.S. FDA Continues Data Integrity Focus

Lina Genovesi

Foreign Particles in Bull’s Eye of Global Reg Agencies

Hirohito Katayama, PhD, Bayer Yakuhin, and John Shabushnig, PhD, Insight Pharma Consulting

A Weeklong Look at Quality Risk Management

Susan Schniepp, Regulatory Compliance Associates

Future of Packaging on Display at Stevanato Tour

Gabriele Peron, Stevanato Group

PDA/FDA JRC Conference Returns!

Program Planning Committee

Excipients' Attributes Crucial for Parenteral Preparations

Elham Blouet, PharmD, ROQUETTE

More than Volcanoes or Solar System Models

Leo Posner, PhD, Johnson & Johnson, and Chapter President, PDA Delaware Valley Chapter