Visual Inspection Training at PDA

John Shabushnig, PhD, Insight Pharma Consulting, LLC

FDA Initiatives Drive 21st Century Advanced Manufacturing Technologies

Claire Briglia, Vedere Solutions

SoCal Chapter Poster Finalist: Launching Drugs During COVID-19

Justin Ratzan-Wank, Master of Business and Science Candidate, Keck Graduate Institute

The Value of Membership

Tia Bush, Amgen, Inc.

Think Big, Leverage and Cooperate to Get COVID-19 Vaccines to People Faster

Martin Van Trieste, President & CEO, Civica Rx

Supporting Early Career Professionals: How the Southern California Chapter Does It

Jason Kerr, Redica Systems

Parenteral Packaging 2021: A Q&A with Conference Chairs

PDA Europe

Voices of the Board: What has the year 2021 in store for us?

Jette Christensen (Novo Nordisk), Chair PDA Board of Directors

President’s Message: A Year Like No Other

Richard Johnson, PDA

The Moldy Nightmare: Questions and Answers, Part 2

Ziva Abraham, Microlite, Inc.

Accelerating Biopharmaceutical Innovation in Health Emergencies

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

A Unique Year of Hidden Treasures

Walter Morris, PDA

The Moldy Nightmare: Questions and Answers, Part 1

Ziva Abraham, Microlite, Inc.

Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-based PACs

Marilyn Foster, PDA

ANNEX 1 Revision Task Force Update

Hal Baseman, ValSource, Gabriele Gori, GSK Vaccines, and Jahanvi Miller, PDA

Think Globally, Work Virtually in the Era of COVID-19: The Future of Biotech Success

Ali Ardakani, Novateur Ventures and Fenton Fong, xCellarate Technology

Getting Closer to AI Adoption in the Pharmaceutical Industry

Tony Manzano, Aizon; Andrej Ondrack, Aizon; Kir Henrici, The Henrici Group

Publishing by the Numbers: An End of an Era

Walter Morris, PDA

Worried about the availability of primary packaging for the COVID Vaccine? It’s a logistics challenge, not a supply challenge

Martin Van Trieste, President & CEO, Civica Rx

5 Steps of Design Thinking

Marilyn Foster, PDA

Continued Process Verification: Reacting to Data Signals

Ajay Babu Pazhayattil, Industrial Pharmacist

Keeping Biopharma’s Essential Services Lifeline Afloat during COVID

Subrata Chakraborty, GxPFONT Consulting Group

Injectable Combination Product Integrated Development: A PDA Live eLearning Course

Fran DeGrazio and Diane Paskiet, West Pharmaceuticals Services, Inc.

Call for Volunteers: New PDA Standard on Biologics Validation/QC

Christine Roberts, PDA

Virtual Audits in the Time of COVID-19: For the Auditor and the Host

Anna Gilbert, BDO; Robert Greathead, Catalent Pharma Solutions; Michelle Bernards, Manager, Catalent Pharma Solutions

Utilizing Modeling in Manufacturing

Marilyn Foster, PDA

Get Published And Noticed!

Walter Morris, PDA

The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

Glenn Wright, PDA

Fifth Annual Women in Life Science Panel Discussion

West Coast Chapter

Data Analytics in Pharmaceutical Manufacturing

Marilyn L. Foster, PDA

Chemical Durability Ratio: Method Provides Leading Indicator of Delamination Risk

Robert Schaut, Kelly Murphy (formerly), Daniel Kramer, Christy Chapman, and Carol Rea Flynn, Corning Inc.

Success Stories: RMM Implementation in the 21st Century

Michael J. Miller, PhD

Joint Associations’ Response Letter on EU Annex 1 Draft

Hal Baseman, Valsource, Inc and Annex 1 Response Team Co-Chair

PDA Requests Pause to USP’s Biologics Nomenclature Proposal

PDA

T-Cell Therapy Saves a Life

Marilyn L. Foster, PDA

We Want You! ATMP Advisory Board Seeks Volunteers

Michael Blackton, Adaptimmune, LLC, and Stephan Krause, PhD, AstraZeneca Diagnostics; ATMP Advisory Board Co-Chairs

2020 PDA Pharmacopeia Conference

Kevin T. Moore, PhD, U. S. Pharmacopeia, and J. Mark Wiggins, Global Pharmacopoeia Solutions LLC

Missouri Valley Chapter Donates to Local Hospitals

Brianna Kempker, Steris Corporation

PDA Survey Results: Current State of Cryopreservation

Brian J. Hawkins, Raluca Marcu, Pluristyx, Inc.

FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

Marilyn Foster, PDA

Volunteers Needed: Event Reporters

Walt Morris, PDA

The House of Data Integrity Compliance

Matthew Paquette, Charles River

Six Q & A’s about Innovation in the Medical Device Industry

The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick

Data Integrity: The New World of Virtual Audits and Investigations

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

PDA IG Explores Next-Gen Sequencing for Viruses

Rebecca Stauffer, PDA

SoCal Chapter Donates Masks to Aid Service Providers

Christy Wong, PDA Southern California Student Chapter President and Student, Keck Graduate Institute

Best Practice Guide for Using KPI’s/Metrics

Bernhard Hinsch, Hinsch Consulting

Global Regulatory Convergence Required to Expand Access to ATMPs

Rebecca Stauffer, PDA

CBER Continues to Analyze Next-Gen Sequencing

Rebecca Stauffer, PDA

A Fond Farewell to Readers

Rebecca Stauffer, PDA

PDA Honor Awards: Honorary Membership

Rebecca Stauffer, PDA

Italy Chapter Looks Ahead

Angela Molaschi, Chapter President

Standard Offers Guide for Supplier Management

Rebecca Stauffer, PDA

Industry Must Move Away from Dye Ingress Test

Oliver Stauffer, PTI

PDA Honor Awards: President’s Award

Rebecca Stauffer, PDA

PDA Honor Awards: Martin VanTrieste, Michael S. Korczynski and Edward Smith Awards

Rebecca Stauffer, PDA

rFC Offers Many Advantages for Industry

Kevin Williams, bioMerieux

Pharma Firm Explores RFID for Prefilled Syringes

Gabriele Peron, Stevanato Group

PDA Honor Awards: Gordon Personeus and Frederick Carleton Awards

Rebecca Stauffer, PDA

PDA Honor Awards: PDA Publications

Rebecca Stauffer, PDA

Risk-Based Approaches to Data Integrity in Manufacturing

Els Poff, Merck, and Technical Report Team Leader

New PDA Task Force Offers Resources for Industry

Anil Sawant, PhD, Merck

The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

William Peterson, Merck & Co.

PDA Honor Awards: EU Service Award and Agalloco Award

Rebecca Stauffer, PDA

St. Gallen Seeks OpEx Info from Industry

Marten Ritz and Thomas Friedli, University of St. Gallen, Switzerland

Regulator Develops Remote Inspection Process Due to Pandemic

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

PDA Honor Awards: Distinguished Service Awards

Rebecca Stauffer, PDA

PDA Honor Awards: Service Appreciation Awards Part II

Rebecca Stauffer, PDA

States Temporarily Relax EtO Restrictions

Rebecca Stauffer, PDA

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