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  • Manufacturing Science

How close are we to closed processing?

  • G (Som) Somasundaram and Priyabrata Pattnaik, PhD, Merck Life Science
  • Jul 27, 2021
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  • Quality & Regulatory

Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

  • Bettine Boltres, West Pharmaceutical Services Deutschland GmbH & Co KG and Lee Leichter, P/L Biomedical
  • Jul 14, 2021
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  • Quality & Regulatory

Modern Quality Professional, Part 3: Using the Scoring System

  • Stephan Krause, Adele Chambers, Ryan Courtney, Darrin Cowley, and Anthony Mire-Sluis, AstraZeneca
  • Jun 23, 2021
  • Article Categories
PDA in Print: Planning for Effective Use of Technology for Remote Inspections

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

Aug 5, 2021
  • Quality & Regulatory
Guest Editorial: Covid-19 Vaccine and High Stakes of Quality

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

Aug 3, 2021
  • Quality & Regulatory
PDA’s Critical Role in Advancing Manufacturing Science

PDA’s Critical Role in Advancing Manufacturing Science

Jul 29, 2021
  • Manufacturing Science
  • People
How close are we to closed processing?

How close are we to closed processing?

Jul 27, 2021
  • Manufacturing Science
The PDA Community Remembers Long-Time Member and Publisher, Amy Davis

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

Jul 22, 2021
  • People
Past Leader Spotlight: Fred Carleton, President 1977-1979, Executive Director 1988-1991

Past Leader Spotlight: Fred Carleton, President 1977-1979, Executive Director 1988-1991

Jul 20, 2021
  • People
Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Virtual EMA Multistakeholder Meeting on Drug-Device Combination Products

Jul 14, 2021
  • Quality & Regulatory
PDA Summer Reading 2021

PDA Summer Reading 2021

Jul 8, 2021
  • People
PDA Southern California Chapter Congratulates PDA Student Chapter Grads

PDA Southern California Chapter Congratulates PDA Student Chapter Grads

Jul 1, 2021
  • People
Past Leader Spotlight: Nathan Kirsch, PDA President 1965-1966

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

Jun 30, 2021
  • People
Modern Quality Professional, Part 3: Using the Scoring System

Modern Quality Professional, Part 3: Using the Scoring System

Jun 23, 2021
  • Quality & Regulatory
President’s Message: PDA Mid-Year Update

President’s Message: PDA Mid-Year Update

Jun 15, 2021
  • People
Breaking Down Computer Systems Validation in a Regulated Environment

Breaking Down Computer Systems Validation in a Regulated Environment

Jun 9, 2021
  • Quality & Regulatory
New Frontiers in Developing and Manufacturing Vaccines

New Frontiers in Developing and Manufacturing Vaccines

Jun 4, 2021
  • Biopharmaceuticals & Biotechnology
Early Career Professionals – Kickstart Your Career with PDA!

Early Career Professionals – Kickstart Your Career with PDA!

May 27, 2021
  • People
Call for Volunteers: The PDA Foundation

Call for Volunteers: The PDA Foundation

May 25, 2021
  • People
Modern Quality Professional, Part 2: The Case Studies

Modern Quality Professional, Part 2: The Case Studies

May 19, 2021
  • Quality & Regulatory
Flexibility—the Future of Manufacturing

Flexibility—the Future of Manufacturing

May 12, 2021
  • Manufacturing Science
Why Industry Cannot Just “Move Away" from the Dye Ingress Test

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

May 5, 2021
  • Manufacturing Science
Pop Quiz: Which Academic Institutions should PDA Work With?

Pop Quiz: Which Academic Institutions should PDA Work With?

Apr 29, 2021
  • People
Remote Audits and Inspections May Be Here to Stay: PDA’s Task Force Aims to Help

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

Apr 27, 2021
  • Quality & Regulatory
COVID-19 and the Sustainability of the LAL Supply

COVID-19 and the Sustainability of the LAL Supply

Apr 22, 2021
  • Manufacturing Science
Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

Happenings at the 2021 PDA Singapore Chapter Annual General Meeting

Apr 13, 2021
  • People
The Modern Quality Professional Development Tool, Part 1

The Modern Quality Professional Development Tool, Part 1

Apr 8, 2021
  • Quality & Regulatory
The Two aspects of Visual Inspection: Process and Technology

The Two aspects of Visual Inspection: Process and Technology

Apr 1, 2021
  • Manufacturing Science
Nominations for PDA Board of Directors Accepted until May 10

Nominations for PDA Board of Directors Accepted until May 10

Mar 30, 2021
  • People
PDA in Print: Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development

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

Mar 25, 2021
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
PDA Annual Meeting and Honor Awards Ceremony Begins 75th Anniversary Celebration

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

Mar 23, 2021
  • People
The Role of Current GMPs in COVID-19 Vaccine Production

The Role of Current GMPs in COVID-19 Vaccine Production

Mar 17, 2021
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
In Print: PDA 2021 Post-Approval Change Issues and Impacts Survey

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

Mar 11, 2021
Visual Inspection Training at PDA

Visual Inspection Training at PDA

Mar 9, 2021
  • Manufacturing Science
FDA Initiatives Drive 21st Century Advanced Manufacturing Technologies

FDA Initiatives Drive 21st Century Advanced Manufacturing Technologies

Mar 4, 2021
  • Manufacturing Science
SoCal Chapter Poster Finalist: Launching Drugs During COVID-19

SoCal Chapter Poster Finalist: Launching Drugs During COVID-19

Feb 26, 2021
  • Manufacturing Science
The Value of Membership

The Value of Membership

Feb 23, 2021
  • People
Think Big, Leverage and Cooperate to Get COVID-19 Vaccines to People Faster

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

Feb 18, 2021
  • Supply Chain & Outsourcing
Supporting Early Career Professionals: How the Southern California Chapter Does It

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

Feb 9, 2021
  • People
Parenteral Packaging 2021: A Q&A with Conference Chairs 

Parenteral Packaging 2021: A Q&A with Conference Chairs 

Feb 3, 2021
  • Supply Chain & Outsourcing
Voices of the Board: What has the year 2021 in store for us?

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

Jan 28, 2021
  • People
President’s Message: A Year Like No Other

President’s Message: A Year Like No Other

Jan 26, 2021
  • People
The Moldy Nightmare: Questions and Answers, Part 2

The Moldy Nightmare: Questions and Answers, Part 2

Jan 20, 2021
  • Aseptic Processing & Sterilization
Accelerating Biopharmaceutical Innovation in Health Emergencies

Accelerating Biopharmaceutical Innovation in Health Emergencies

Jan 15, 2021
  • Biopharmaceuticals & Biotechnology
A Unique Year of Hidden Treasures

A Unique Year of Hidden Treasures

Jan 8, 2021
  • People
The Moldy Nightmare: Questions and Answers, Part 1

The Moldy Nightmare: Questions and Answers, Part 1

Jan 6, 2021
  • Aseptic Processing & Sterilization
Facilitating Continual Improvement, Innovation, and Reducing Drug Shortages through Enhanced Science and Risk-based PACs

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

Dec 17, 2020
  • Quality & Regulatory
ANNEX 1 Revision Task Force Update

ANNEX 1 Revision Task Force Update

Dec 15, 2020
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
Think Globally, Work Virtually in the Era of COVID-19: The Future of Biotech Success

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

Dec 10, 2020
  • Biopharmaceuticals & Biotechnology
Getting Closer to AI Adoption in the Pharmaceutical Industry

Getting Closer to AI Adoption in the Pharmaceutical Industry

Dec 8, 2020
  • Manufacturing Science
Publishing by the Numbers: An End of an Era

Publishing by the Numbers: An End of an Era

Dec 4, 2020
  • People
Worried about the availability of primary packaging for the COVID Vaccine? It’s a logistics challenge, not a supply challenge

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

Dec 2, 2020
  • Supply Chain & Outsourcing
5 Steps of Design Thinking

5 Steps of Design Thinking

Nov 19, 2020
  • Quality & Regulatory
Continued Process Verification: Reacting to Data Signals

Continued Process Verification: Reacting to Data Signals

Nov 18, 2020
  • Manufacturing Science
Keeping Biopharma’s Essential Services Lifeline Afloat during COVID

Keeping Biopharma’s Essential Services Lifeline Afloat during COVID

Nov 11, 2020
  • Supply Chain & Outsourcing
Injectable Combination Product Integrated Development: A PDA Live eLearning Course

Injectable Combination Product Integrated Development: A PDA Live eLearning Course

Nov 5, 2020
  • Manufacturing Science
Call for Volunteers: New PDA Standard on Biologics Validation/QC

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

Nov 3, 2020
  • Biopharmaceuticals & Biotechnology
  • Quality & Regulatory
  • People
Virtual Audits in the Time of COVID-19: For the Auditor and the Host

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

Oct 28, 2020
  • Quality & Regulatory
Utilizing Modeling in Manufacturing

Utilizing Modeling in Manufacturing

Oct 23, 2020
  • Manufacturing Science
Get Published And Noticed!

Get Published And Noticed!

Oct 20, 2020
  • People
The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

The Product Quality Research Institute – Advancing Regulatory Science through Collaboration

Oct 14, 2020
  • Quality & Regulatory
Fifth Annual Women in Life Science Panel Discussion

Fifth Annual Women in Life Science Panel Discussion

Oct 8, 2020
  • People
Data Analytics in Pharmaceutical Manufacturing

Data Analytics in Pharmaceutical Manufacturing

Oct 6, 2020
  • Manufacturing Science
Chemical Durability Ratio: Method Provides Leading Indicator of Delamination Risk

Chemical Durability Ratio: Method Provides Leading Indicator of Delamination Risk

Oct 2, 2020
  • Manufacturing Science
Success Stories: RMM Implementation in the 21st Century

Success Stories: RMM Implementation in the 21st Century

Sep 30, 2020
  • Manufacturing Science
  • Aseptic Processing & Sterilization
Joint Associations’ Response Letter on EU Annex 1 Draft

Joint Associations’ Response Letter on EU Annex 1 Draft

Sep 24, 2020
  • Aseptic Processing & Sterilization
  • Quality & Regulatory
PDA Requests Pause to USP’s Biologics Nomenclature Proposal

PDA Requests Pause to USP’s Biologics Nomenclature Proposal

Sep 22, 2020
  • Quality & Regulatory
T-Cell Therapy Saves a Life

T-Cell Therapy Saves a Life

Sep 17, 2020
  • Biopharmaceuticals & Biotechnology
We Want You! ATMP Advisory Board Seeks Volunteers

We Want You! ATMP Advisory Board Seeks Volunteers

Sep 16, 2020
  • People
  • Biopharmaceuticals & Biotechnology
2020 PDA Pharmacopeia Conference

2020 PDA Pharmacopeia Conference

Sep 15, 2020
  • Quality & Regulatory
Missouri Valley Chapter Donates to Local Hospitals

Missouri Valley Chapter Donates to Local Hospitals

Sep 9, 2020
  • People
PDA Survey Results: Current State of Cryopreservation

PDA Survey Results: Current State of Cryopreservation

Sep 3, 2020
  • Biopharmaceuticals & Biotechnology
FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

FDA Shares Views on ICH Q12, Continuous Improvement and Innovation

Aug 26, 2020
  • Quality & Regulatory
Volunteers Needed: Event Reporters

Volunteers Needed: Event Reporters

Aug 25, 2020
  • People
The House of Data Integrity Compliance

The House of Data Integrity Compliance

Aug 20, 2020
  • Quality & Regulatory
Six Q & A’s about Innovation in the Medical Device Industry

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

Aug 18, 2020
  • Manufacturing Science
The Evolution of USP <800>: A Q&A with Cathy Zhao and Allison Radwick

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

Aug 13, 2020
  • Manufacturing Science
Data Integrity: The New World of Virtual Audits and Investigations

Data Integrity: The New World of Virtual Audits and Investigations

Aug 6, 2020
  • Quality & Regulatory
PDA IG Explores Next-Gen Sequencing for Viruses

PDA IG Explores Next-Gen Sequencing for Viruses

Aug 3, 2020
  • Biopharmaceuticals & Biotechnology
SoCal Chapter Donates Masks to Aid Service Providers

SoCal Chapter Donates Masks to Aid Service Providers

Jul 28, 2020
  • People
Best Practice Guide for Using KPI’s/Metrics

Best Practice Guide for Using KPI’s/Metrics

Jul 22, 2020
  • Quality & Regulatory
Global Regulatory Convergence Required to Expand Access to ATMPs

Global Regulatory Convergence Required to Expand Access to ATMPs

Jul 16, 2020
  • Biopharmaceuticals & Biotechnology
CBER Continues to Analyze Next-Gen Sequencing

CBER Continues to Analyze Next-Gen Sequencing

Jul 9, 2020
  • Biopharmaceuticals & Biotechnology

A Fond Farewell to Readers

Jul 9, 2020
  • People

PDA Honor Awards: Honorary Membership

Jul 7, 2020
  • People
Italy Chapter Looks Ahead

Italy Chapter Looks Ahead

Jul 7, 2020
  • People
Standard Offers Guide for Supplier Management

Standard Offers Guide for Supplier Management

Jul 2, 2020
  • Supply Chain & Outsourcing
Industry Must Move Away from Dye Ingress Test

Industry Must Move Away from Dye Ingress Test

Jun 30, 2020
  • Manufacturing Science

PDA Honor Awards: President’s Award

Jun 29, 2020
  • People

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

Jun 25, 2020
  • People
rFC Offers Many Advantages for Industry

rFC Offers Many Advantages for Industry

Jun 25, 2020
  • Aseptic Processing & Sterilization
Pharma Firm Explores RFID for Prefilled Syringes

Pharma Firm Explores RFID for Prefilled Syringes

Jun 23, 2020
  • Supply Chain & Outsourcing

PDA Honor Awards: Gordon Personeus and Frederick Carleton Awards

Jun 22, 2020
  • People

PDA Honor Awards: PDA Publications

Jun 18, 2020
  • People
Risk-Based Approaches to Data Integrity in Manufacturing

Risk-Based Approaches to Data Integrity in Manufacturing

Jun 17, 2020
  • Regulatory
New PDA Task Force Offers Resources for Industry

New PDA Task Force Offers Resources for Industry

Jun 16, 2020
  • People
The Use of Scientific Data to Assess and Control Risks Associated with Sterilizing Filtration

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

Jun 15, 2020
  • Aseptic Processing & Sterilization

PDA Honor Awards: EU Service Award and Agalloco Award

Jun 11, 2020
  • People
St. Gallen Seeks OpEx Info from Industry

St. Gallen Seeks OpEx Info from Industry

Jun 11, 2020
  • Quality & Regulatory
Regulator Develops Remote Inspection Process Due to Pandemic

Regulator Develops Remote Inspection Process Due to Pandemic

Jun 9, 2020
  • Quality & Regulatory

PDA Honor Awards: Distinguished Service Awards

Jun 9, 2020
  • People

PDA Honor Awards: Service Appreciation Awards Part II

Jun 9, 2020
  • People
States Temporarily Relax EtO Restrictions

States Temporarily Relax EtO Restrictions

Jun 4, 2020
  • Aseptic Processing & Sterilization