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

By: 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

By: 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

By: 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

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

Aseptic Technology Advances to the Next Level

Subrata Chakraborty, Cipla

Gloveless Isolators Offer Speedy Throughput

By: 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

By: Jason O’Hare, Charles River

Air Bubbles versus Transparent Particles

John MacEwen, Körber Medipak Systems NA Inc

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.

Change is in the Air for Packaging Components

Rebecca Stauffer, PDA

Biopharma Offers New Opportunities

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

A Roadmap to a Continuous Control Strategy

By: Per Vase, PhD, NNE

PUPSIT & the Proposed Annex 1 Revision

By: Hal Baseman, ValSource, Inc.

Expand Your Network and Have Fun!

Rebecca Stauffer, PDA

Thanks for the Warning Letter: Part II

By: 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

Alternative to LAL Gains Ground

Stephenie Overman

Regulatory Concerns Drive New Developments in Glass Packaging

Rebecca Stauffer, PDA

An Overview of Container Closure Integrity

By: 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

Industry and Regulators Convene to Address Vaccines Challenges

Industry 4.0 and Drug Manufacturing

Walter Alexander

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

Rebecca Stauffer, PDA

Hidden Contamination in Starting Materials

By: Annette Kirsch, PhD, Merck KGaA

Process, Interrupted

Fatima Hasanain, Polymer Materials Specialist, Nordion (Canada) Inc.

Thanks for the Warning Letter: Part I

By: Steven Lynn, Lynn Consulting, LLC

Glass Breakage in Pharmaceutical Packaging

By: 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

Modular Manufacturing Begins to Take Hold

David Pittman

West Coast Chapter Hosts Women in Biopharma Panel

Lori Richter, ValSource

Future Challenges in Visual Inspection Processes

John Shabushnig, PhD, Insight Pharma Consulting, and Markus Lankers, PhD, Mibic GmbH

Big Data, Pharma 4.0 and Legacy Products

By: Jana Spes, Boston Biomedical and Wayne Levin, Predictum

Big Data: The Panacea for Pharma’s Ills?

By: 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

Going Beyond Patient Preference

Nic Bowman, Pfizer

Build Connections at Two PDA Events

Rebecca Stauffer, PDA

Drug Delivery Combination Products Go “Viral”

Lee Leichter, P/L Biomedical

What Annex 1 Means for Sterilization and Moist Steam

Walid El Azab, STERIS Life Science

Data Integrity in the Age of Metadata and Big Data

Toni Manzano, bigfinite

Biologics Packaging Presents Risks

Alessandro Morandotti, Ompi

Draft Annex 1 Separates Cleaning and Disinfection

James Tucker, Ecolab Life Sciences

Revised USP Micro Chapters Address Changing Technologies

David Hussong, PhD, Eagle Analytical Services, Radhakrishna Tirumalai, PhD, USP, Edward Tidswell, PhD, Merck, and Donald Singer, GSK

Strategies to Address E/L Container Closure Challenges

Rebecca Stauffer, PDA

Russian GMP Inspections Present Challenges, Opportunities: Part II

Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen

Russian GMP Inspections Present Challenges, Opportunities: Part I

Vladislav Shestakov, Russian State Institute of Drugs and Good Practices, and Elizabeth Meyers, Amgen

Not So Different After All

Rebecca Stauffer, PDA

Reclaiming Efficiency Amid Serialization Nightmares

Vito Pirrera and John Jordon, Vantage Solutions

Evaluating Cell Viability After Cryopreservation

Brian J. Hawkins, Alireza Abazari, Aby J. Mathew, BioLife Solutions

New Serialization Regs Impact Global Pharma

Darryl Peterson, Antares Vision

A Risk-Based Approach to Supplier Management

Rebecca Stauffer and Aneeta Mathur-Ashton, PDA

Viscous Product No Match for New CCI Tech

By: Oliver Stauffer, PTI

Blockchain: Will it Transform the Pharmaceutical Supply Chain?

Mark Crawford

A Not-So-Sweet Smell: Part II

By: Anthony Newcombe, PhD, PAREXEL Consulting and Siegfried Schmitt, PAREXEL Consulting

Quality/Compliance Management for Virtual Companies

By: David Chesney, DL Chesney Consulting

Five Critical Endotoxin Testing Concerns

Jennifer Farrington, PhD, Associates of Cape Cod, and Friedrich von Wintzingerode, PhD, Roche Diagnostics GmbH