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Effective AI Deployment in Drug Manufacturing

by: Peter Makowenskyj, MEng, G-CON Manufacturing and Toni Manzano, PhD, Aizon

Engineering Excellence in Container Closure Integrity Testing

by: Oliver Stauffer

The mRNA Revolution

by: Amisha Patel

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
Tri-Spine Crab Now on Endangered List

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
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
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
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

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

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
Future of Packaging on Display at Stevanato Tour

Gabriele Peron, Stevanato Group
PDA/FDA JRC Conference Returns!

Program Planning Committee
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
Aseptic Technology Advances to the Next Level

Subrata Chakraborty, Cipla
Gloveless Isolators Offer Speedy Throughput

Jim Akers, PhD, Akers Kennedy and Associates

Cell and Gene Manufacturing Grows in Singapore

Bruce Loxley, GSK, and Emily Cheah, Charles River Laboratories, Members-at-Large, PDA Singapore Chapter

Highly Potent APIs: Balancing Patient and Operator Safety

Rebecca Stauffer, PDA
PDA Comments: Drug Storage Regulations in Plain Language

Rebecca Stauffer, PDA

Robotics and AI Have Much to Offer Pharma

Martin Düblin, One One Eleven
Rock Out at the 4th PDA Europe Annual Meeting

Rebecca Stauffer, PDA
The Future of Pharma is Coming to Europe

Borke Van Belle, Janssen J&J, and Toni Manzano, Bigfinite
A Patient’s Life Depends on Product Quality

Jason O’Hare, Charles River

The Pharmacopeia in the 21st Century

Susanne Keitel, PhD, EDQM
Future Lies in Continuous Manufacturing Technology

Bei Ma, Pinea Group
B. cepacia: What is it and Why is it a Concern?

Marc Baiget Francesch, Tiselab
Deep Dive into Biosimilars Continues

Stephan Krause, AstraZeneca, Emanuela Lacana, U.S. FDA, and Rebecca Stauffer, PDA
Rapid Micro Methods Carry Potential

Tony Cundell, PhD, Microbiological Consulting, and Michael Miller, PhD, Microbiology Consultants
PDA Addresses LER in TR, Forthcoming Book

Rebecca Stauffer, PDA
Our Data Integrity Journey Has Only Just Begun

Jackie Veivia-Panter, Legend Biotech
The Challenges of Visually Inspecting IV Bags

Florian Krickl, Vitronic
Viruses on the Surface

Jennifer Loughman and Paul Lopolito, STERIS
Industry Eyes Future of Visual Inspection

John Shabushnig, PhD, Insight Pharma Consulting; Markus Lankers, PhD, MIBIC; John Ayres, MD, Pharma Safety Solutions; Roy Cherris, Bridge Associates; Robert Miller, Pfizer; Romain Veillon, GSK Vaccines; and Rick Watson, Merck

Big Data is Here to Stay

Aaron Goerke, PhD, F. Hoffmann-La Roche AG, and Michele D’Alessandro, Merck & Company, Inc.
Can the Power of Viruses be Harnessed for Good?

Brian Hawkins, PhD, Pluristyx, Inc.
Biopharma Offers New Opportunities

Cristiana Campa, GSK, and Michael De Felippis, Eli Lilly and Company
A Roadmap to a Continuous Control Strategy

Per Vase, PhD, NNE

PUPSIT & the Proposed Annex 1 Revision

Hal Baseman, ValSource, Inc.

Expand Your Network and Have Fun!

Rebecca Stauffer, PDA
Thanks for the Warning Letter: Part II

Steven Lynn, Lynn Consulting, LLC

Response to "Standing Guard"

Kevin L. Williams, bioMérieux
Are You Up to Speed with Pharma’s Evolving Landscape?

Magaly E. Aham, Takeda Pharmaceuticals
Growth Promotion Testing For EM

Brendan Tindall, biomerieux, and Graham Vesey, Regeneus
Data Integrity Validated as Key Issue

Bruce Loxley, GSK Vaccines, PDA Singapore Chapter Member-at-Large
Regulatory Concerns Drive New Developments in Glass Packaging

Rebecca Stauffer, PDA
An Overview of Container Closure Integrity

Qingyu Zeng, PhD, West Pharmaceutical Services, Inc.

Are You (and Pharma) Ready for the Future?

Karen Walker, Seattle Genetics, and Tia Bush, Amgen
EMA's Amsterdam Move Reflects Larger Trend

Toni Manzano, bigfinite
Holistic Verification Requires a New Mindset

David Hubmayr, CSL Behring
FDA's ORA Realignment, MRA, NIPP, Concept of Operations: How it All Fits Together

Rebecca Stauffer, PDA
Hidden Contamination in Starting Materials

Annette Kirsch, PhD, Merck KGaA

Process, Interrupted

Fatima Hasanain, Polymer Materials Specialist, Nordion (Canada) Inc.
Thanks for the Warning Letter: Part I

Steven Lynn, Lynn Consulting, LLC

Glass Breakage in Pharmaceutical Packaging

Carina Bronnbauer, PhD, SCOTT

Risk Management Shines Light on ICH Q12 Use for Biologics

Jose C. Menezes, PhD, 4Tune Engineering
PDA Forms New Chapter in Pacific Northwest

Rebecca Stauffer, PDA
West Coast Chapter Hosts Women in Biopharma Panel

Lori Richter, ValSource
Big Data, Pharma 4.0 and Legacy Products

Jana Spes, Boston Biomedical and Wayne Levin, Predictum

Big Data: The Panacea for Pharma’s Ills?

Khan Lau, Promedica International

Build Your CCI Knowledge Base Through Data, Tech

Jaime Cobo, WILCO AG
Hot Read: GMP in Practice

Rebecca Stauffer, PDA
New Perspectives on Freeze-Drying

Thomas Beutler, GEA, and Yves Mayeresse, GSK
Standing Guard

John Dubczak, Charles River Laboratories
Endotoxin Testing Using Recombinant Reagents

Karolina Heed, Hyglos - a bioMérieux company
Deep Learning in the Information Swamp

Heino Prinz, Rommelag
Does QRM + RMM = Better EM?

Dalmaso Gilberto, PhD, and Lisa G. Lawson, Particle Measuring Systems