PDA Letter
PDA in Print: Planning for Effective Use of Technology for Remote Inspections

PDA, Inc.

Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

Tamer Helmy, PhD, Molecular Templates Inc.

PDA’s Critical Role in Advancing Manufacturing Science

Mary Oates, Emergent BioSolutions

How close are we to closed processing?

G (Som) Somasundaram and Priyabrata Pattnaik, PhD, Merck Life Science

The PDA Community Remembers Long-Time Member and Publisher, Amy Davis

PDA, Inc.

Past Leader Spotlight: Fred Carleton, President 1977-1979, Executive Director 1988-1991
Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Bettine Boltres, West Pharmaceutical Services Deutschland GmbH & Co KG and Lee Leichter, P/L Biomedical

PDA Summer Reading 2021

PDA, Inc.

PDA Southern California Chapter Congratulates PDA Student Chapter Grads

PDA Southern California Chapter

Past Leader Spotlight: Nathan Kirsch, PDA President 1965-1966

Bob Myers, PDA

Modern Quality Professional, Part 3: Using the Scoring System

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

President’s Message: PDA Mid-Year Update

Richard Johnson, PDA

Breaking Down Computer Systems Validation in a Regulated Environment

Ray Roggero, Medvacon Life Sciences

New Frontiers in Developing and Manufacturing Vaccines

Marilyn Foster, PDA, Inc.

Early Career Professionals – Kickstart Your Career with PDA!

Bettine Boltres, West Pharmaceutical Services Deutschland GmbH & Co KG

Call for Volunteers: The PDA Foundation

Richard M. Johnson, President, PDA Foundation

Modern Quality Professional, Part 2: The Case Studies

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

Flexibility—the Future of Manufacturing

Marilyn L. Foster, PDA

Why Industry Cannot Just “Move Away" from the Dye Ingress Test

Klaus Wuchner, Janssen, et al.

Pop Quiz: Which Academic Institutions should PDA Work With?

PDA Letter

Remote Audits and Inspections May Be Here to Stay: PDA’s Task Force Aims to Help

Task Force Co-Chairs Eva M. Urban, CSL Behring, and Tiffany Baker, ValSource, LLC

COVID-19 and the Sustainability of the LAL Supply

Brett Hoffmeister, Associates of Cape Cod, Inc., Allen Burgenson, Lonza, and John Dubczak, Charles River Laboratories

Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

Richard Chai, STERIS Corporation, Priyabrata Pattnaik, Merck Pte. Ltd., and Bruce Loxley, GSK

The Modern Quality Professional Development Tool, Part 1

Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca

The Two aspects of Visual Inspection: Process and Technology

John Ayres, MD, Pharma Safety Solutions, LLC and Rob Miller, MS, Pfizer Inc.

Nominations for PDA Board of Directors Accepted until May 10

PDA, Inc.

PDA in Print: Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development

M. Amin Khan and Cristiana Campa, GSK

PDA Annual Meeting and Honor Awards Ceremony Begins 75th Anniversary Celebration

PDA, Inc.

The Role of Current GMPs in COVID-19 Vaccine Production

Tony Cundell, PhD, Microbiological Consulting, LLC and PDA COVID-19 Pandemic Task Force

In Print: PDA 2021 Post-Approval Change Issues and Impacts Survey

PDA, Inc.

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