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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

Microbial Ingress No Longer an Effective CCI Test Method

by: Oliver Stauffer and Tyler Harris

Understanding Japan Quality

by: Antonio Burazer

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
PDA Comments: PDA Input on USP 2020-2025 Revision Cycle

Rebecca Stauffer, PDA
How to Qualify Your Disinfectants

Michael Hodgkinson, Orvera Scientific
FDA Takes Close Look at Innovation

Rebecca Stauffer, PDA
PDA Comments: PDA Responds to EMA Combo Product Reg

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
PDA Comments: Suggestions for FDA Voluntary Recalls Doc

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
PDA Comments: Concerns About USP <1235> Revision

Rebecca Stauffer, PDA
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 Comments: Full Support for WHO WFI Guidance

Rebecca Stauffer, PDA
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
PDA Comments: Ph. Eur. Tackles Endotoxin Alternative rFC

Rebecca Stauffer, PDA
New ISO Standard Available for Water Systems

Shlomo Sackstein, Biopuremax
The Role of Project Managers in Pharma

Kerstin Wilken, PhD, PDA